ENT Irrigation Syringe Suppliers
Limit companies to: Worldwide USA
Medtronic Xomed Surgical Products, Inc | Address: 6743 Southpoint Drive North, Jacksonville, Florida 32216-0980, USA 
www.xomed.com | Phone: +1-(904)-296-9600, 800-874-5797
FDA Registration: 1045254 Year Established: 1999 Annual Revenues: USD 500 Million to 1 Billion Employee Count: ~650 Quality: ISO 9001, CE Certified
Products: Sinus Trochars and Cannulae, Surgical Navigation Interface/Display, Nerve Stimulators, Eyeshields, General Diagnostic Supplies, General Surgical Aids, ...
Medtronic Xomed Surgical Products, Inc develops products that treat people with ear, nose and throat (ENT) diseases. our products include MeroPack®, Bioresorbable Nasal Dressing and Sinus Stent, I more...
www.xomed.com | Phone: +1-(904)-296-9600, 800-874-5797
FDA Registration: 1045254 Year Established: 1999 Annual Revenues: USD 500 Million to 1 Billion Employee Count: ~650 Quality: ISO 9001, CE Certified
Products: Sinus Trochars and Cannulae, Surgical Navigation Interface/Display, Nerve Stimulators, Eyeshields, General Diagnostic Supplies, General Surgical Aids, ...
Medtronic Xomed Surgical Products, Inc develops products that treat people with ear, nose and throat (ENT) diseases. our products include MeroPack®, Bioresorbable Nasal Dressing and Sinus Stent, I more...
KLS Martin, L.P. | Address: 11239-1 St.Johns Industrial Parkway S, Jacksonville, Florida 32246-7652, USA
www.klsmartinusa.com | Send Inquiry | Phone: +1-(904)-641-7746, 800-625-1557
FDA Registration: 1057946 Year Established: 1993 Annual Revenues: USD 10-25 Million Employee Count: ~100 Quality: ISO 9001 Certified
Products: Elevators, Instruments, Castroviejo Calipers, Neurological Instruments, Pituitary Scoops, Cervical Spine Retractor System, Hand Held Instruments, Periosteals Elevators, ...
KLS Martin, L.P. focuses on surgical fields. Our mario® instrument management software manages & controls sterile supplies according to economic, technical & process-oriented criteria. Our C-plate more...
www.klsmartinusa.com | Send Inquiry | Phone: +1-(904)-641-7746, 800-625-1557
FDA Registration: 1057946 Year Established: 1993 Annual Revenues: USD 10-25 Million Employee Count: ~100 Quality: ISO 9001 Certified
Products: Elevators, Instruments, Castroviejo Calipers, Neurological Instruments, Pituitary Scoops, Cervical Spine Retractor System, Hand Held Instruments, Periosteals Elevators, ...
KLS Martin, L.P. focuses on surgical fields. Our mario® instrument management software manages & controls sterile supplies according to economic, technical & process-oriented criteria. Our C-plate more...
Vyaire Medical, Inc. | Address: 26125 North Riverwoods Blvd, Mettawa, Illinois 60045, USA
www.vyaire.com | Send Inquiry | Phone: +1-(610)-862-0800
FDA Registration: 2050001 Year Established: 2001 Annual Revenues: USD 50-100 Million Employee Count: ~230 Quality: ISO 9001, CE Certified
Products: Speech & Testing Equipment, Impedance Testing Systems, Audiometers & Accessories, Evoked Response Testing Systems, Infant Screening & Testing Units, Otoacoustic Emission Test Equipment, ...
Vyaire Medical, Inc. develops & distributes technology medical devices that are used in respiratory care, neurology, vascular medicine and critical care. Our Infant Flow® SiPAP™ renders bi-l more...
www.vyaire.com | Send Inquiry | Phone: +1-(610)-862-0800
FDA Registration: 2050001 Year Established: 2001 Annual Revenues: USD 50-100 Million Employee Count: ~230 Quality: ISO 9001, CE Certified
Products: Speech & Testing Equipment, Impedance Testing Systems, Audiometers & Accessories, Evoked Response Testing Systems, Infant Screening & Testing Units, Otoacoustic Emission Test Equipment, ...
Vyaire Medical, Inc. develops & distributes technology medical devices that are used in respiratory care, neurology, vascular medicine and critical care. Our Infant Flow® SiPAP™ renders bi-l more...
Luxtec | Address: 99 Hartwell Street, West Boylston, Maryland 01583, USA
www.luxtec.com | Send Inquiry | Phone: +1-(508)-835-9700
Year Established: 1981 Annual Revenues: USD 10-25 Million Employee Count: ~140 Quality: ISO 9001, CE Certified
Products: Light Sources, Surgical Headlights, Recording Systems, Headlight Box / Light source, Digital Video Recorders, Recording Devices, ...
Luxtec produces medical illumination systems. We develop lighting and visualization systems for the operating room. Our products include headlights, ultralite, halogen, camera, surgical loupes, monito more...
www.luxtec.com | Send Inquiry | Phone: +1-(508)-835-9700
Year Established: 1981 Annual Revenues: USD 10-25 Million Employee Count: ~140 Quality: ISO 9001, CE Certified
Products: Light Sources, Surgical Headlights, Recording Systems, Headlight Box / Light source, Digital Video Recorders, Recording Devices, ...
Luxtec produces medical illumination systems. We develop lighting and visualization systems for the operating room. Our products include headlights, ultralite, halogen, camera, surgical loupes, monito more...
Ranfac Corp. | Address: 30 Doherty Avenue, P.O. Box 635, Avon, Massachusetts 02322, USA
www.ranfac.com | Send Inquiry | Phone: +1-(508)-588-4400, (800)-272-6322
FDA Registration: 3011555966 Year Established: 1888 Annual Revenues: USD 10-25 Million Employee Count: ~50 Quality: ISO, CE Certified
Products: Stainless Steel Brain Biopsy Needles, Cholangiography Catheters (FDA Code: GBZ), Pneumoperitoneum Insufflation Needle, Multipurpose Knot Pusher Ligator, Soft Tissue Biopsy Needles, Percutaneous Introducer, ...
Ranfac Corp. supplies precision medical instruments for surgeons, radiologists and hematologists. Our product list comprises of disposable cholangiography catheters, percutaneous introducers, galactog more...
www.ranfac.com | Send Inquiry | Phone: +1-(508)-588-4400, (800)-272-6322
FDA Registration: 3011555966 Year Established: 1888 Annual Revenues: USD 10-25 Million Employee Count: ~50 Quality: ISO, CE Certified
Products: Stainless Steel Brain Biopsy Needles, Cholangiography Catheters (FDA Code: GBZ), Pneumoperitoneum Insufflation Needle, Multipurpose Knot Pusher Ligator, Soft Tissue Biopsy Needles, Percutaneous Introducer, ...
Ranfac Corp. supplies precision medical instruments for surgeons, radiologists and hematologists. Our product list comprises of disposable cholangiography catheters, percutaneous introducers, galactog more...
Jedmed Instrument Company | Address: 5416 JEDMED Court, St. Louis, Missouri 63129-2221, USA
www.jedmed.com | Send Inquiry | Phone: +1-(314)-845-3770
FDA Registration: 1926681 Annual Revenues: < USD 1 Million Employee Count: ~40 Quality: ISO Certified
Products: Dry Heat Sterilizers (FDA Code: KMH), Laboratory Sterilizers, Endoscopes, Laboratory Steam Sterilizers, Benchtop Steam Sterilizers, Endoscopes, Stabilization and Steering, ...
Jedmed Instrument Company manufactures instruments in the areas of ENT, opthalmology and dentistry. Our endonasal DCR technique uses a fiberoptic probe inserted in the punctum for guidance. Our kaps t more...
www.jedmed.com | Send Inquiry | Phone: +1-(314)-845-3770
FDA Registration: 1926681 Annual Revenues: < USD 1 Million Employee Count: ~40 Quality: ISO Certified
Products: Dry Heat Sterilizers (FDA Code: KMH), Laboratory Sterilizers, Endoscopes, Laboratory Steam Sterilizers, Benchtop Steam Sterilizers, Endoscopes, Stabilization and Steering, ...
Jedmed Instrument Company manufactures instruments in the areas of ENT, opthalmology and dentistry. Our endonasal DCR technique uses a fiberoptic probe inserted in the punctum for guidance. Our kaps t more...
Bausch & Lomb | Address: 1400 N. Goodman St., Rochester, New York 14609, USA
www.bausch.com | Send Inquiry | Phone: +1-(585)-338-6000, 800-553-5340
FDA Registration: 1920664 Annual Revenues: USD 100-500 Million Employee Count: ~1000 Quality: ISO 9000, ISO 9001, ISO 9002, CE Certified
Products: Daily Wear Soft Contact Lenses (FDA Code: LPL), Extended Wear Soft Contact Lenses (FDA Code: LPM), Soft Contact Lense Rinsing Solutions, Soft Contact Lens Storage Solutions, Contact Lens Eye Drops, Soft Contact Lenses For Extended Wear, ...
Bausch & Lomb is the eye health company dedicated to perfecting vision and enhancing life. We offer a comprehensive portfolio of eye health products. Our three broad categories of products are vision more...
www.bausch.com | Send Inquiry | Phone: +1-(585)-338-6000, 800-553-5340
FDA Registration: 1920664 Annual Revenues: USD 100-500 Million Employee Count: ~1000 Quality: ISO 9000, ISO 9001, ISO 9002, CE Certified
Products: Daily Wear Soft Contact Lenses (FDA Code: LPL), Extended Wear Soft Contact Lenses (FDA Code: LPM), Soft Contact Lense Rinsing Solutions, Soft Contact Lens Storage Solutions, Contact Lens Eye Drops, Soft Contact Lenses For Extended Wear, ...
Bausch & Lomb is the eye health company dedicated to perfecting vision and enhancing life. We offer a comprehensive portfolio of eye health products. Our three broad categories of products are vision more...
Teleflex Medical | Address: PO Box 12600, Research Triangle Park, North Carolina 27709, USA
www.teleflexmedical.com | Send Inquiry | Phone: +1-(919)-544-8000
FDA Registration: 1044475 Annual Revenues: USD 50-100 Million Employee Count: ~380 Quality: ISO 9001, CE Certified
Products: Absorbable Sutures (FDA Code: GAK), General Diagnostic Supplies, General Medical Supplies, General Sutures/Needles, Non-Absorbable Sutures (FDA Code: GAO), Suture Needles, ...
Teleflex Medical, a division of Teleflex Incorporated, is a supplier of medical devices, surgical instruments & disposable medical products. We are a global outsource provider that focuses on medical more...
www.teleflexmedical.com | Send Inquiry | Phone: +1-(919)-544-8000
FDA Registration: 1044475 Annual Revenues: USD 50-100 Million Employee Count: ~380 Quality: ISO 9001, CE Certified
Products: Absorbable Sutures (FDA Code: GAK), General Diagnostic Supplies, General Medical Supplies, General Sutures/Needles, Non-Absorbable Sutures (FDA Code: GAO), Suture Needles, ...
Teleflex Medical, a division of Teleflex Incorporated, is a supplier of medical devices, surgical instruments & disposable medical products. We are a global outsource provider that focuses on medical more...
Aesculap Inc. | Address: 3773 Corporate Parkway, Center Valley, Pennsylvania 18034, USA
www.aesculapusa.com | Send Inquiry | Phone: +1-(800)-258-1946
FDA Registration: 2916714 Year Established: 1977 Annual Revenues: USD 1-5 Million Employee Count: ~120
Products: Curettes, Drills, Titanium Plating Systems, Suction Tubes, Dural Substitute, Posterior, ...
Aesculap Inc. manufactures surgical instrumentation. Our products include surgical instruments, laparoscopy, endoscopy, neurosurgery, sutrures, surgical quality management, and consulting services. Ou more...
www.aesculapusa.com | Send Inquiry | Phone: +1-(800)-258-1946
FDA Registration: 2916714 Year Established: 1977 Annual Revenues: USD 1-5 Million Employee Count: ~120
Products: Curettes, Drills, Titanium Plating Systems, Suction Tubes, Dural Substitute, Posterior, ...
Aesculap Inc. manufactures surgical instrumentation. Our products include surgical instruments, laparoscopy, endoscopy, neurosurgery, sutrures, surgical quality management, and consulting services. Ou more...
Miltex, Inc. | Address: 589 Davies Drive, York, Pennsylvania 17402, USA
www.miltex.com | Send Inquiry | Phone: +1-(717)-840-9335
FDA Registration: 2523190 Year Established: 1950 Employee Count: ~200 Quality: ISO 9001, CE Certified
Products: Forceps (FDA Code: HTD), Scissors, Vasectomy Ringed Forceps, Vasectomy Hemostats, General Medical Supplies, General Surgical Instruments, ...
Miltex, Inc. specializes in surgical and dental instruments. Our product line includes surgical, dental, gynecology, animal health, podiatry and repair instruments. Our Miltex® endometrial samplin more...
www.miltex.com | Send Inquiry | Phone: +1-(717)-840-9335
FDA Registration: 2523190 Year Established: 1950 Employee Count: ~200 Quality: ISO 9001, CE Certified
Products: Forceps (FDA Code: HTD), Scissors, Vasectomy Ringed Forceps, Vasectomy Hemostats, General Medical Supplies, General Surgical Instruments, ...
Miltex, Inc. specializes in surgical and dental instruments. Our product line includes surgical, dental, gynecology, animal health, podiatry and repair instruments. Our Miltex® endometrial samplin more...
Boss Instruments, Ltd. | Address: 395 Reas Ford Road, Suite 120, Earlysville, Virginia 22936, USA
www.bossinst.com | Send Inquiry | Phone: +1-(800)-210-2677
FDA Registration: 1056350 Year Established: 1990 Annual Revenues: < USD 1 Million Employee Count: ~10 Quality: ISO 9000, ISO 9002, CE Certified
Products: Tissue Forceps, Sinus Trochars and Cannulae, Tourniquets, Vascular Clamps (FDA Code: DXC), Adjustable Bone Holding Forceps, Dilators, ...
Boss Instruments, Ltd. is a surgical instrument company which concentrates on the manufacture and continual development of specialty lines of instruments include ear, nose, and throat, general surgery more...
www.bossinst.com | Send Inquiry | Phone: +1-(800)-210-2677
FDA Registration: 1056350 Year Established: 1990 Annual Revenues: < USD 1 Million Employee Count: ~10 Quality: ISO 9000, ISO 9002, CE Certified
Products: Tissue Forceps, Sinus Trochars and Cannulae, Tourniquets, Vascular Clamps (FDA Code: DXC), Adjustable Bone Holding Forceps, Dilators, ...
Boss Instruments, Ltd. is a surgical instrument company which concentrates on the manufacture and continual development of specialty lines of instruments include ear, nose, and throat, general surgery more...
Amsino International, Inc | Address: 855 Towne Center Drive, Pomona, California 91767, USA
www.amsino.com | Send Inquiry | Phone: +1-(906)-626-5888
FDA Registration: 2085175 Year Established: 1993 Annual Revenues: USD 25-50 Million Employee Count: ~500 Quality: ISO 9001, CE Certified
Products: Adult Tracheostomy Mask, Aspirators, Disposable Leg Bags, Cervical Scrapers, Central Line Dressing Change Trays, Coiled Sterile Suction Catheter, ...
Amsino International, Inc is an ISO 9001 certified company. We manufacture disposable medical products. We specialize in urology, general feeding with irrigation, IV therapy products, surgical, genera more...
www.amsino.com | Send Inquiry | Phone: +1-(906)-626-5888
FDA Registration: 2085175 Year Established: 1993 Annual Revenues: USD 25-50 Million Employee Count: ~500 Quality: ISO 9001, CE Certified
Products: Adult Tracheostomy Mask, Aspirators, Disposable Leg Bags, Cervical Scrapers, Central Line Dressing Change Trays, Coiled Sterile Suction Catheter, ...
Amsino International, Inc is an ISO 9001 certified company. We manufacture disposable medical products. We specialize in urology, general feeding with irrigation, IV therapy products, surgical, genera more...
Hi Tech International Group Inc | Address: 4301 Oak Circle, Suite 18, Boca Raton, Florida 33431, USA
www.htig.com | Send Inquiry | Phone: +1-(561)-367-8760
Products: Consulting Services, Medical Ultrasound Devices, Nuclear Medicine, MRI Reselling Service, Endoscopy Consulting, Radiology Tables, ...
Hi Tech International Group Inc distributes used and refurbished diagnostic medical systems. We offer refurbished X-ray system, CT scanners, ultrasound system, nuclear medicine, MRI, CT scanners and m more...
www.htig.com | Send Inquiry | Phone: +1-(561)-367-8760
Products: Consulting Services, Medical Ultrasound Devices, Nuclear Medicine, MRI Reselling Service, Endoscopy Consulting, Radiology Tables, ...
Hi Tech International Group Inc distributes used and refurbished diagnostic medical systems. We offer refurbished X-ray system, CT scanners, ultrasound system, nuclear medicine, MRI, CT scanners and m more...
Biomet Microfixation | Address: 1520 Tradeport Dr., Jacksonville, Florida 32218-2480, USA
www.biometmicrofixation.com | Send Inquiry | Phone: +1-(904)-741-4400, 800-874-7711
FDA Registration: 1032347 Year Established: 1965
Products: Basic Plastic Surgery Tray, Blepharoplasty Tray, Craniofacial Surgery Tray, Biopsy Trays, Bone Graft Replacement, Angle Blade Plate Instrument, ...
Biomet Microfixation manufactures a complete range of craniomaxillofacial products. We offer products for neurosurgical, plastic, oral & maxillofacial, craniofacial, pediatric, ENT and cardiothoracic more...
www.biometmicrofixation.com | Send Inquiry | Phone: +1-(904)-741-4400, 800-874-7711
FDA Registration: 1032347 Year Established: 1965
Products: Basic Plastic Surgery Tray, Blepharoplasty Tray, Craniofacial Surgery Tray, Biopsy Trays, Bone Graft Replacement, Angle Blade Plate Instrument, ...
Biomet Microfixation manufactures a complete range of craniomaxillofacial products. We offer products for neurosurgical, plastic, oral & maxillofacial, craniofacial, pediatric, ENT and cardiothoracic more...
Sawyer Products, Inc. | Address: P.O. Box 188, Safety Harbor, Florida 34695, USA
www.sawyerproducts.com | Send Inquiry | Phone: +1-(800)-356.7811
FDA Registration: 2082653
Products: Water Filtration Units, First Aid Kits, Medical First Aid Response Kit, Emergency First Aid Kit (FDA Code: LRR), Non-Sterile Absorbent Tipped Applicator (FDA Code: KXF), Surgical Orthopedic Scissors (FDA Code: HRR), ...
Sawyer Products, Inc. specializes in first aid kits, Extractor® pump kit and sun care products. Our first aid kits include pocket first aid kit, individual first aid kit, group first aid kit, wate more...
www.sawyerproducts.com | Send Inquiry | Phone: +1-(800)-356.7811
FDA Registration: 2082653
Products: Water Filtration Units, First Aid Kits, Medical First Aid Response Kit, Emergency First Aid Kit (FDA Code: LRR), Non-Sterile Absorbent Tipped Applicator (FDA Code: KXF), Surgical Orthopedic Scissors (FDA Code: HRR), ...
Sawyer Products, Inc. specializes in first aid kits, Extractor® pump kit and sun care products. Our first aid kits include pocket first aid kit, individual first aid kit, group first aid kit, wate more...
Ear-Clear, Inc. | Address: Po Box 8976, Sebring, Florida 33872, USA
www.earclear.com | Phone: +1-(866)-290-4260
Products: ENT Syringe (FDA Code: KCP), Ear Syringes Repair Service, Baby Ear Syringe, Electric Ear Syringe, ENT Irrigation Syringe (FDA Code: KCP), Non Dental Irrigating Syringe (FDA Code: KYZ), ...
Ear-Clear, Inc. is a provider of ear irrigation syringes. Our syringe is a self-use earwax remover. It can be used with warm water, and no chemicals are needed. Ear canals are gently flushed clean by more...
www.earclear.com | Phone: +1-(866)-290-4260
Products: ENT Syringe (FDA Code: KCP), Ear Syringes Repair Service, Baby Ear Syringe, Electric Ear Syringe, ENT Irrigation Syringe (FDA Code: KCP), Non Dental Irrigating Syringe (FDA Code: KYZ), ...
Ear-Clear, Inc. is a provider of ear irrigation syringes. Our syringe is a self-use earwax remover. It can be used with warm water, and no chemicals are needed. Ear canals are gently flushed clean by more...
Peco Medical, Inc. | Address: 203 Chandler Walk, Loganville, Georgia 30052, USA
FDA Registration: 3007866129
Products: ENT Irrigation Syringe (FDA Code: KCP), Urine Collector and Accessories (FDA Code: KNX), ...
Peco Medical, Inc. offers hospital and urological supplies. We offer ENT syringes, urine collector and accessories. more...
FDA Registration: 3007866129
Products: ENT Irrigation Syringe (FDA Code: KCP), Urine Collector and Accessories (FDA Code: KNX), ...
Peco Medical, Inc. offers hospital and urological supplies. We offer ENT syringes, urine collector and accessories. more...
Envisionier Medical Technologies, Inc. | Address: 7828 Hickory Flat Highway, Suite 120, Woodstock, Georgia 30188, USA
www.envisionier.com | Send Inquiry | Phone: (888)-3636461
Products: Devices For Telemedicine, Diagnostic Laryngoscopy Equipment, Biopsy System, Biopsy Kit, Endoscopic Still Camera (FDA Code: FXM), Endoscopic Video Camera, ...
Envisionier Medical Technologies, Inc. specializes in endoscopic technologies and products. Our products include endogo®HD, endogo® and eGoWorks™. The endogorHD merges data acquisition w more...
www.envisionier.com | Send Inquiry | Phone: (888)-3636461
Products: Devices For Telemedicine, Diagnostic Laryngoscopy Equipment, Biopsy System, Biopsy Kit, Endoscopic Still Camera (FDA Code: FXM), Endoscopic Video Camera, ...
Envisionier Medical Technologies, Inc. specializes in endoscopic technologies and products. Our products include endogo®HD, endogo® and eGoWorks™. The endogorHD merges data acquisition w more...
LSL Industries Inc. | Address: 5535 N Wolcott Ave, Chicago, Illinois 60640-1019, USA
www.lslhealthcare.com | Send Inquiry | Phone: +1-(773)-878-1100
FDA Registration: 1420054 Year Established: 1981 Annual Revenues: USD 10-25 Million Employee Count: ~40 Quality: ISO Certified
Products: General Medical Supplies, Suturing Kits & Removal Kits, Barium Accessories, Empty Enema Kit, Enteral Irrigation Kit w/Piston Syringe, Enema Kit, Piston Syringe (FDA Code: FMF), ...
LSL Industries Inc. offers a wide variety of disposable medical devices, component parts, various hospital supplies, disposable kits and surgical procedure kits. We also offer drainage bags, preconnec more...
www.lslhealthcare.com | Send Inquiry | Phone: +1-(773)-878-1100
FDA Registration: 1420054 Year Established: 1981 Annual Revenues: USD 10-25 Million Employee Count: ~40 Quality: ISO Certified
Products: General Medical Supplies, Suturing Kits & Removal Kits, Barium Accessories, Empty Enema Kit, Enteral Irrigation Kit w/Piston Syringe, Enema Kit, Piston Syringe (FDA Code: FMF), ...
LSL Industries Inc. offers a wide variety of disposable medical devices, component parts, various hospital supplies, disposable kits and surgical procedure kits. We also offer drainage bags, preconnec more...
Dental USA, Inc. | Address: 5005 Mccullom Lake Rd., Mchenry, Illinois 60050, USA
www.mydentalusa.com | Send Inquiry | Phone: +1-(815)-363-8003, 866-439-3400
FDA Registration: 3003969055
Products: Calipers, Dental Elevators, Dental Explorers, Baby Ear Syringe, Calipers (FDA Code: KTZ), Curettes (FDA Code: HTF), ...
Dental USA, Inc. manufactures instruments for all branches of dental surgery. We offer a full line of stainless steel instruments. Our products include composite kit, endodontic, gingival grafting, im more...
www.mydentalusa.com | Send Inquiry | Phone: +1-(815)-363-8003, 866-439-3400
FDA Registration: 3003969055
Products: Calipers, Dental Elevators, Dental Explorers, Baby Ear Syringe, Calipers (FDA Code: KTZ), Curettes (FDA Code: HTF), ...
Dental USA, Inc. manufactures instruments for all branches of dental surgery. We offer a full line of stainless steel instruments. Our products include composite kit, endodontic, gingival grafting, im more...
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FDA Code / Regulation: KCP / 874.5220
An ear, nose, and throat drug administration device is one of a group of ear, nose, and throat devices intended specifically to administer medicinal substances to treat ear, nose, and throat disorders. These instruments include the powder blower, dropper, ear wick, manual nebulizer pump, and nasal inhaler.
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in 874.9. If the device is not labeled or otherwise represented as sterile, it is exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of 820.180, with respect to general requirements concerning records, and 820.198, with respect to complaint files.
