Non Dental Irrigating Syringe Suppliers
Limit companies to: Worldwide USA
Arjon Industries | Address: 7550 N. Broadway, St. Louis, Missouri 63147, USA 
www.arjonindustries.com | Send Inquiry | Phone: +1-(314)-383-2879
Products: Adhesive Bandages (FDA Code: KGX), Blood Collection Lancet (FDA Code: FMK), Conductive Shoe and Shoe Cover (FDA Code: BWP), Disposable Medical Bed (FDA Code: KME), Emesis Basin (FDA Code: FNY), Incontinence Protective Garment (FDA Code: EYQ), ...
Arjon Industries deals with Kitpackers systems. Our kits are customizable, pursuant to end-user specifications, and samples are readily available for clinical evaluations. Our products include cathete more...
www.arjonindustries.com | Send Inquiry | Phone: +1-(314)-383-2879
Products: Adhesive Bandages (FDA Code: KGX), Blood Collection Lancet (FDA Code: FMK), Conductive Shoe and Shoe Cover (FDA Code: BWP), Disposable Medical Bed (FDA Code: KME), Emesis Basin (FDA Code: FNY), Incontinence Protective Garment (FDA Code: EYQ), ...
Arjon Industries deals with Kitpackers systems. Our kits are customizable, pursuant to end-user specifications, and samples are readily available for clinical evaluations. Our products include cathete more...
J & J Instruments, Inc. | Address: 737 East Elizabeth Ave., Linden, New Jersey 07036, USA
www.jjinstruments.com | Send Inquiry | Phone: +1-(908)-4863800
FDA Registration: 2246990
Products: Anesthesia Equipment, Nasal Specula, Catheter Forceps, Forceps, Ear, Ear Forceps, Ear Curette (FDA Code: JYG), ...
J & J Instruments, Inc. manufactures medical, dental and veterinary instruments. Our dental products include amalgam carrier, amalgam condensers and pluggers, burnishers, carvers, cotton & dressing fo more...
www.jjinstruments.com | Send Inquiry | Phone: +1-(908)-4863800
FDA Registration: 2246990
Products: Anesthesia Equipment, Nasal Specula, Catheter Forceps, Forceps, Ear, Ear Forceps, Ear Curette (FDA Code: JYG), ...
J & J Instruments, Inc. manufactures medical, dental and veterinary instruments. Our dental products include amalgam carrier, amalgam condensers and pluggers, burnishers, carvers, cotton & dressing fo more...
Derma Sciences, Inc. | Address: 214 Carnegie Center Suite 300, Princeton, New Jersey 08540, USA
www.dermasciences.com | Send Inquiry | Phone: +1-(609)-514.4744
FDA Registration: 9680091 Year Established: 1991 Annual Revenues: USD 5-10 Million Employee Count: ~20
Products: Gauze, Gauze Dressings, Packings, Self-Adherent Wraps/Bandages, Tubular Gauzes, Ulcer, Burn & Wound Dressings, ...
Derma Sciences, Inc. manufactures & markets a complete line of products for wound and skin care. Our products can be broken down into five categories including advanced wound care, traditional wound c more...
www.dermasciences.com | Send Inquiry | Phone: +1-(609)-514.4744
FDA Registration: 9680091 Year Established: 1991 Annual Revenues: USD 5-10 Million Employee Count: ~20
Products: Gauze, Gauze Dressings, Packings, Self-Adherent Wraps/Bandages, Tubular Gauzes, Ulcer, Burn & Wound Dressings, ...
Derma Sciences, Inc. manufactures & markets a complete line of products for wound and skin care. Our products can be broken down into five categories including advanced wound care, traditional wound c more...
The Medtech Group, Inc. | Address: 6 Century Road, South Plainfield, New Jersey 07080, USA
www.medtech-grp.com | Send Inquiry | Phone: +1-(908)-561-0717
FDA Registration: 2244012 Year Established: 1979 Annual Revenues: USD 10-25 Million Employee Count: ~170 Quality: ISO 9001:2000, ISO 13485:2003 Certified
Products: Non Dental Irrigating Syringe (FDA Code: KYZ), Anesthetic Conduction Needle with/without Introducer (FDA Code: BSP), General & Plastic Surgery Surgical Cannula (FDA Code: GEA), Removable Skin Clip (FDA Code: FZQ), Cement Dispenser (FDA Code: KIH), Microwave Hyperthermia System (FDA Code: MEQ), ...
The Medtech Group, Inc. is a contract medical device manufacturer. We are a full service contract manufacturer of medical devices and components. We provide complete services from product design to pa more...
www.medtech-grp.com | Send Inquiry | Phone: +1-(908)-561-0717
FDA Registration: 2244012 Year Established: 1979 Annual Revenues: USD 10-25 Million Employee Count: ~170 Quality: ISO 9001:2000, ISO 13485:2003 Certified
Products: Non Dental Irrigating Syringe (FDA Code: KYZ), Anesthetic Conduction Needle with/without Introducer (FDA Code: BSP), General & Plastic Surgery Surgical Cannula (FDA Code: GEA), Removable Skin Clip (FDA Code: FZQ), Cement Dispenser (FDA Code: KIH), Microwave Hyperthermia System (FDA Code: MEQ), ...
The Medtech Group, Inc. is a contract medical device manufacturer. We are a full service contract manufacturer of medical devices and components. We provide complete services from product design to pa more...
Ethox International, Inc. | Address: 251 Seneca Street, Buffalo, New York 14204-2088, USA
www.ethoxcorp.com | Send Inquiry | Phone: +1-(716)-842.4000, 800.521.1022
FDA Registration: 1314417 Year Established: 1966 Annual Revenues: USD 10-25 Million
Products: CPR Equipment, General EMT, General Medical Supplies, General Urology Supplies, General Surgical Aids, General Surgery Supplies, ...
Ethox International, Inc. provides the medical device and pharmaceutical industries integrated OEM design and manufacturing, sterilization, toxicology, analytical chemistry, and microbiology. We also more...
www.ethoxcorp.com | Send Inquiry | Phone: +1-(716)-842.4000, 800.521.1022
FDA Registration: 1314417 Year Established: 1966 Annual Revenues: USD 10-25 Million
Products: CPR Equipment, General EMT, General Medical Supplies, General Urology Supplies, General Surgical Aids, General Surgery Supplies, ...
Ethox International, Inc. provides the medical device and pharmaceutical industries integrated OEM design and manufacturing, sterilization, toxicology, analytical chemistry, and microbiology. We also more...
Pedia Pals LLC | Address: 230 Grider St., Buffalo, New York 14215, USA
www.pediapals.com | Send Inquiry | Phone: +1-(888)-733-427
Products: Calipers, Exam Tables, Hammers, General Medical Supplies, Ophthalmoscope Aids, Aspirators, ...
Pedia Pals, LLC designs, manufactures and markets pediatric medical equipment & supplies. Our exam tables, room decal kits and accessories help to deliver high quality heath care. Our Pedia Pals Jamaa more...
www.pediapals.com | Send Inquiry | Phone: +1-(888)-733-427
Products: Calipers, Exam Tables, Hammers, General Medical Supplies, Ophthalmoscope Aids, Aspirators, ...
Pedia Pals, LLC designs, manufactures and markets pediatric medical equipment & supplies. Our exam tables, room decal kits and accessories help to deliver high quality heath care. Our Pedia Pals Jamaa more...
Busse Hospital Disposables | Address: P.O. Box 11067, Hauppauge, New York 11788-0920, USA
www.busseinc.com | Send Inquiry | Phone: +1-(631)-435-4711, (800)-645-6526
FDA Registration: 2433012
Products: Curettes, Forceps (FDA Code: HTD), Scissors, Gastroenterologic Needle Holder (FDA Code: FHQ), Bags, Wraps & Tubing, Aspirators, ...
Busse Hospital Disposables specializes in emerging hospital disposables. Our urine catheter kit consists of smooth tapered catheter tip and eyes for low trauma insertions. Its unique vended lid promot more...
www.busseinc.com | Send Inquiry | Phone: +1-(631)-435-4711, (800)-645-6526
FDA Registration: 2433012
Products: Curettes, Forceps (FDA Code: HTD), Scissors, Gastroenterologic Needle Holder (FDA Code: FHQ), Bags, Wraps & Tubing, Aspirators, ...
Busse Hospital Disposables specializes in emerging hospital disposables. Our urine catheter kit consists of smooth tapered catheter tip and eyes for low trauma insertions. Its unique vended lid promot more...
Dukal Corporation | Address: 5 Plant Avenue, Hauppauge, New York 11788, USA
www.dukal.com | Send Inquiry | Phone: +1-(631)-656-3800
FDA Registration: 2435946 Year Established: 1991 Annual Revenues: USD 25-50 Million Employee Count: ~40 Quality: ISO 9002 Certified
Products: Scrubs, Adhesive Surgical Paper, Cotton Sponges, Cotton, Rayon Supplies, Elastic Wrap, Casting Materials, ...
Dukal Corporation specializes in gauze products. We deliver a wide variety of wound care & specialty patient care products for all medical markets. We offer the medical community a solution in disposa more...
www.dukal.com | Send Inquiry | Phone: +1-(631)-656-3800
FDA Registration: 2435946 Year Established: 1991 Annual Revenues: USD 25-50 Million Employee Count: ~40 Quality: ISO 9002 Certified
Products: Scrubs, Adhesive Surgical Paper, Cotton Sponges, Cotton, Rayon Supplies, Elastic Wrap, Casting Materials, ...
Dukal Corporation specializes in gauze products. We deliver a wide variety of wound care & specialty patient care products for all medical markets. We offer the medical community a solution in disposa more...
Asept Pak Inc. | Address: 64 West Street, Malone, New York 12953, USA
www.aseptpak.com | Send Inquiry | Phone: +1-(518)-651-2026
FDA Registration: 3007177643
Products: Packaging, Non Dental Irrigating Syringe (FDA Code: KYZ), Suction Catheter and Tip (FDA Code: JOL), Ocular Surgery Irrigation Device (FDA Code: KYG), Hydrogel Wound Dressing (W/Out Drug And/Or Biologic) (FDA Code: NAE), Aseptic Packaging, ...
Asept Pak Inc. focuses on contract blow-fill-seal packaging. We package products for intranasal, inhalation, ophthalmic, prescription pharmaceuticals, oral liquids, and topical liquids like creams, ge more...
www.aseptpak.com | Send Inquiry | Phone: +1-(518)-651-2026
FDA Registration: 3007177643
Products: Packaging, Non Dental Irrigating Syringe (FDA Code: KYZ), Suction Catheter and Tip (FDA Code: JOL), Ocular Surgery Irrigation Device (FDA Code: KYG), Hydrogel Wound Dressing (W/Out Drug And/Or Biologic) (FDA Code: NAE), Aseptic Packaging, ...
Asept Pak Inc. focuses on contract blow-fill-seal packaging. We package products for intranasal, inhalation, ophthalmic, prescription pharmaceuticals, oral liquids, and topical liquids like creams, ge more...
Dynarex Corporation | Address: 10 Glenshaw Street, Orangeburg, New York 10962, USA
www.dynarex.com | Send Inquiry | Phone: +1-(845)-365-8200, (888)-335-7500
FDA Registration: 3003467879 Annual Revenues: USD 25-50 Million Employee Count: ~30 Quality: CE Certified
Products: Bags, Wraps & Tubing, Caps, Bathing Caps, Athletic Elastic Wraps and Tapes, Aspirators, Antimicrobial Wipes, ...
Dynarex Corporation supplies antiseptic products, incontinent care, gloves, patient care, wound care, nursing and urologicals. Our PVP iodine ointment is an antiseptic, antimicrobial ointment, which i more...
www.dynarex.com | Send Inquiry | Phone: +1-(845)-365-8200, (888)-335-7500
FDA Registration: 3003467879 Annual Revenues: USD 25-50 Million Employee Count: ~30 Quality: CE Certified
Products: Bags, Wraps & Tubing, Caps, Bathing Caps, Athletic Elastic Wraps and Tapes, Aspirators, Antimicrobial Wipes, ...
Dynarex Corporation supplies antiseptic products, incontinent care, gloves, patient care, wound care, nursing and urologicals. Our PVP iodine ointment is an antiseptic, antimicrobial ointment, which i more...
Closure Medical | Address: 5250 Greens Dairy Rd., Raleigh, North Carolina 27616, USA
Phone: +1-(919)-876-7800, 888-257-7633
Annual Revenues: USD 10-25 Million Employee Count: ~80 Quality: ISO 9001, CE Certified
Products: Suture Free Wound Closure Adhesives, Wound Closure Adhesive (FDA Code: MGO), Vascular Device for Promoting Embolization (FDA Code: KRD), Topical Approximation of Skin Tissue Adhesive (FDA Code: MPN), Waterproof Adhesive Strip, Ophthalmology Tissue Adhesive (FDA Code: LZQ), ...
Closure Medical are providers of nexacryl and n-butyl cyanoacrylate for treatment of corneal ulcerations. Dermabond is a topical skin adhesive. Nexaband family n-butyl cyanacrylate and 2-octyl cyanoac more...
Phone: +1-(919)-876-7800, 888-257-7633
Annual Revenues: USD 10-25 Million Employee Count: ~80 Quality: ISO 9001, CE Certified
Products: Suture Free Wound Closure Adhesives, Wound Closure Adhesive (FDA Code: MGO), Vascular Device for Promoting Embolization (FDA Code: KRD), Topical Approximation of Skin Tissue Adhesive (FDA Code: MPN), Waterproof Adhesive Strip, Ophthalmology Tissue Adhesive (FDA Code: LZQ), ...
Closure Medical are providers of nexacryl and n-butyl cyanoacrylate for treatment of corneal ulcerations. Dermabond is a topical skin adhesive. Nexaband family n-butyl cyanacrylate and 2-octyl cyanoac more...
Health Care Logistics | Address: PO Box 25, Circleville, Ohio 43113-0025, USA
www.hcl-intl.com | Send Inquiry | Phone: +1-(800)-848-1633
FDA Registration: 1530671 Year Established: 1978 Employee Count: ~120
Products: Adhesive Bandages (FDA Code: KGX), Acid and Corrosive Chemical Storage, Polypropylene Cabinets, Adhesive Elastic Bandage Tape, Angular Ear Curette, Anesthesiology Oropharyngeal Airway (FDA Code: CAE), Anesthesia Table and Tray Cabinet (FDA Code: BRY), ...
Health Care Logistics supplies emergency products, pharmacy products, infection control products, key cabinets & tablet crushers. Our extensive line of daily aids include ideas such as medication orga more...
www.hcl-intl.com | Send Inquiry | Phone: +1-(800)-848-1633
FDA Registration: 1530671 Year Established: 1978 Employee Count: ~120
Products: Adhesive Bandages (FDA Code: KGX), Acid and Corrosive Chemical Storage, Polypropylene Cabinets, Adhesive Elastic Bandage Tape, Angular Ear Curette, Anesthesiology Oropharyngeal Airway (FDA Code: CAE), Anesthesia Table and Tray Cabinet (FDA Code: BRY), ...
Health Care Logistics supplies emergency products, pharmacy products, infection control products, key cabinets & tablet crushers. Our extensive line of daily aids include ideas such as medication orga more...
Bionix Development Corporation | Address: 5154 Enterprise Blvd., Toledo, Ohio 43612, USA
www.bionix.com | Send Inquiry | Phone: +1-(800)-551-7096
FDA Registration: 1526854 Year Established: 1984 Annual Revenues: USD 1-5 Million Employee Count: ~40
Products: Curettes, Forceps (FDA Code: HTD), General Medical Supplies, General Surgical Aids, General Hypodermic Supplies, Nasal & Ear Specula, ...
Bionix Development Corporation develops, manufactures and markets medical devices. Our articulating safe ear curette™ is the only curette that articulates to assist in the removal of cerumen fro more...
www.bionix.com | Send Inquiry | Phone: +1-(800)-551-7096
FDA Registration: 1526854 Year Established: 1984 Annual Revenues: USD 1-5 Million Employee Count: ~40
Products: Curettes, Forceps (FDA Code: HTD), General Medical Supplies, General Surgical Aids, General Hypodermic Supplies, Nasal & Ear Specula, ...
Bionix Development Corporation develops, manufactures and markets medical devices. Our articulating safe ear curette™ is the only curette that articulates to assist in the removal of cerumen fro more...
Xodus Medical, Inc. | Address: Westmoreland Business & Research Park, 702 Prominence Drive, New Kensington, Pennsylvania 15068, USA
www.xodusmedical.com | Send Inquiry | Phone: +1-(724)-337-5500, 800-963-8776
FDA Registration: 2530138 Year Established: 1994 Annual Revenues: USD 1-5 Million Employee Count: ~40 Quality: ISO 9000, CE Certified
Products: Face Masks, Bowls & Basins, Foam Block Needle Counters, Cautery Tip Cleaner, Bulb Irrigation Syringe, Electrosurgical Tip Cleaner, ...
Xodus Medical, Inc. specializes in offering medical safety products. We offer a wide range of products including surgical EZ kits™, safety products, custom medication labels, electrosurgical, pa more...
www.xodusmedical.com | Send Inquiry | Phone: +1-(724)-337-5500, 800-963-8776
FDA Registration: 2530138 Year Established: 1994 Annual Revenues: USD 1-5 Million Employee Count: ~40 Quality: ISO 9000, CE Certified
Products: Face Masks, Bowls & Basins, Foam Block Needle Counters, Cautery Tip Cleaner, Bulb Irrigation Syringe, Electrosurgical Tip Cleaner, ...
Xodus Medical, Inc. specializes in offering medical safety products. We offer a wide range of products including surgical EZ kits™, safety products, custom medication labels, electrosurgical, pa more...
Alcon Manufacturing, Ltd. | Address: 714 Columbia Ave., Sinking Spring, Pennsylvania 19608, USA
www.alcon.com | Phone: +1-(610)-670.3500
FDA Registration: 2523835
Products: Disposable Irrigating Syringe, Enteral Irrigation Kit w/Piston Syringe, Piston Syringe (FDA Code: FMF), Non Dental Irrigating Syringe (FDA Code: KYZ), Ophthalmic Cannula (FDA Code: HMX), Surgical Ophthalmic Cannula (FDA Code: HMX), ...
Alcon Manufacturing, Ltd. is a provider of eye care products. We develop, manufacture and market surgical equipment & devices, pharmaceutical eye drops & consumer vision care products to treat eye dis more...
www.alcon.com | Phone: +1-(610)-670.3500
FDA Registration: 2523835
Products: Disposable Irrigating Syringe, Enteral Irrigation Kit w/Piston Syringe, Piston Syringe (FDA Code: FMF), Non Dental Irrigating Syringe (FDA Code: KYZ), Ophthalmic Cannula (FDA Code: HMX), Surgical Ophthalmic Cannula (FDA Code: HMX), ...
Alcon Manufacturing, Ltd. is a provider of eye care products. We develop, manufacture and market surgical equipment & devices, pharmaceutical eye drops & consumer vision care products to treat eye dis more...
Salimetrics, LLC | Address: 101 Innovation Blvd., Suite 302, State College, Pennsylvania 16803, USA
www.salimetrics.com | Send Inquiry | Phone: +1-(814)-234-7748, 800-790-2258
FDA Registration: 3003760091 Year Established: 1998 Quality: ISO, CE Certified
Products: Cortisol, C-reactive Protein Assay, Diagnostic Kits, Disposable Oral Swab, Diagnostic Test Kits, Bar Code Label, ...
Salimetrics, LLC offers products for behavioral, social and medically-focused researchers. Our products are salivary assays, collection supplies, DNA analysis and saliva testing services. We develop s more...
www.salimetrics.com | Send Inquiry | Phone: +1-(814)-234-7748, 800-790-2258
FDA Registration: 3003760091 Year Established: 1998 Quality: ISO, CE Certified
Products: Cortisol, C-reactive Protein Assay, Diagnostic Kits, Disposable Oral Swab, Diagnostic Test Kits, Bar Code Label, ...
Salimetrics, LLC offers products for behavioral, social and medically-focused researchers. Our products are salivary assays, collection supplies, DNA analysis and saliva testing services. We develop s more...
Cadence Inc. | Address: 2080 Plainfield Pike, Cranston, Rhode Island 02921, USA
www.cadenceinc.com | Send Inquiry | Phone: +1-(401)-942-1031, 800-252-3371
FDA Registration: 1213649 Year Established: 1922
Products: Anesthesia Needle Tips, Dispensing Tips, 3-Way Stop Cock, Disposable Dispensing Needle, Catheter Adaptor (FDA Code: GCE), Biopsy Needle Kit (FDA Code: FCG), ...
Cadence Inc. is a supplier of standard & customized metal tubular components, connectors, and syringes for scientific testing, sampling, diagnostic & dispensing applications. We make custom probes, ne more...
www.cadenceinc.com | Send Inquiry | Phone: +1-(401)-942-1031, 800-252-3371
FDA Registration: 1213649 Year Established: 1922
Products: Anesthesia Needle Tips, Dispensing Tips, 3-Way Stop Cock, Disposable Dispensing Needle, Catheter Adaptor (FDA Code: GCE), Biopsy Needle Kit (FDA Code: FCG), ...
Cadence Inc. is a supplier of standard & customized metal tubular components, connectors, and syringes for scientific testing, sampling, diagnostic & dispensing applications. We make custom probes, ne more...
Cara, Inc. | Address: 255 Warwick Industrial Drive, Warwick, Rhode Island 02886-2417, USA
www.caraincorporated.com | Send Inquiry | Phone: +1-(401)-732 6535
FDA Registration: 1221553
Products: Syringes, Ice Bags (FDA Code: KYR), Heating Pads, Vinyl Synthetic Exam Gloves, Non Dental Irrigating Syringe (FDA Code: KYZ), Electrical Heating Pad, ...
Cara, Inc. is a manufacturer and distributor of water bottles/fountain syringes, ice bags/ice packs, electric heating pads, microwave heating pads, feminine syringes, vinyl gloves, dermatological cott more...
www.caraincorporated.com | Send Inquiry | Phone: +1-(401)-732 6535
FDA Registration: 1221553
Products: Syringes, Ice Bags (FDA Code: KYR), Heating Pads, Vinyl Synthetic Exam Gloves, Non Dental Irrigating Syringe (FDA Code: KYZ), Electrical Heating Pad, ...
Cara, Inc. is a manufacturer and distributor of water bottles/fountain syringes, ice bags/ice packs, electric heating pads, microwave heating pads, feminine syringes, vinyl gloves, dermatological cott more...
Deroyal Technologies, Inc. | Address: 1211 Hwy. 33 South, New Tazewell, Tennessee 37825, USA
Phone: +1-(865)-938-7828
Products: Blood pressure Cuffs (FDA Code: DXQ), Blood Pressure Cuffs With Locking-Type Connectors, Blood Pressure Cuff With Inflation Systems, Bone Clamp (FDA Code: HXD), Blood Pressure Cuff Barriers, Automatic Surgical Stapler (FDA Code: GAG), ...
Deroyal Technologies, Inc. offers blood pressure monitors and various types of surgical staplers. Our products include bulb syringe, ear syringe, suction canister, skin marker, therapeutic cooling uni more...
Phone: +1-(865)-938-7828
Products: Blood pressure Cuffs (FDA Code: DXQ), Blood Pressure Cuffs With Locking-Type Connectors, Blood Pressure Cuff With Inflation Systems, Bone Clamp (FDA Code: HXD), Blood Pressure Cuff Barriers, Automatic Surgical Stapler (FDA Code: GAG), ...
Deroyal Technologies, Inc. offers blood pressure monitors and various types of surgical staplers. Our products include bulb syringe, ear syringe, suction canister, skin marker, therapeutic cooling uni more...
Kentron Health Care, Inc. | Address: 3604 Kelton Jackson Rd., Springfield, Tennessee 37172, USA
www.kentronmedical.com | Send Inquiry | Phone: +1-(866)-385-0573
FDA Registration: 1062671
Products: Cardiology Stethoscope, Blood Glucose Test Strips, Aneroid Sphygmomanometer, Cold & Hot Packs, Blood Glucose Monitor Kit, Body Bag, Cadaver, ...
Kentron Health Care, Inc. is a manufacturer of surgical and medical instruments. Our product line includes sterile and non sterile latex gloves, vinyl & polyethylene gloves, hospital plastics, nursing more...
www.kentronmedical.com | Send Inquiry | Phone: +1-(866)-385-0573
FDA Registration: 1062671
Products: Cardiology Stethoscope, Blood Glucose Test Strips, Aneroid Sphygmomanometer, Cold & Hot Packs, Blood Glucose Monitor Kit, Body Bag, Cadaver, ...
Kentron Health Care, Inc. is a manufacturer of surgical and medical instruments. Our product line includes sterile and non sterile latex gloves, vinyl & polyethylene gloves, hospital plastics, nursing more...
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FDA Code / Regulation: KYZ / 880.6960
An irrigating syringe is a device intended for medical purposes that consists of a bulb or a piston syringe with an integral or a detachable tube. The device is used to irrigate, withdraw fluid from, or instill fluid into, a body cavity or wound.
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 880.9. If the device is not labeled or otherwise represented as sterile, it is also 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.
