Ice Bags Suppliers
Limit companies to: Worldwide USA
Hospital Marketing Services Co., Inc. | Address: PO Box 1217, 162 Great Hill Road, Naugatuck, Connecticut 06770-1217, USA 
www.hmsmedical.com | Send Inquiry | Phone: +1-(800)-786-5094
Employee Count: ~50 Quality: CE Certified
Products: Heat or Cold Packs, Scalpels, Surgical Blades, Surgical Scalpels, Suture Needles, Disposable Scalpels, ...
Hospital Marketing Services Co., Inc. is a source for instant thermal products for hot & cold therapies, as well as skin markers, suture needles, scalpels, surgical blades, thermal binders and abdomin more...
www.hmsmedical.com | Send Inquiry | Phone: +1-(800)-786-5094
Employee Count: ~50 Quality: CE Certified
Products: Heat or Cold Packs, Scalpels, Surgical Blades, Surgical Scalpels, Suture Needles, Disposable Scalpels, ...
Hospital Marketing Services Co., Inc. is a source for instant thermal products for hot & cold therapies, as well as skin markers, suture needles, scalpels, surgical blades, thermal binders and abdomin more...
Halyard Health, Inc. | Address: 5405 Windward Parkway, Alpharetta, Georgia 30004, USA
https://www.halyardhealth.com | Phone: 844-HALYARD (425-9273)
FDA Registration: 3011270181 Year Established: 1903 Annual Revenues: > USD 1 Billion Employee Count: ~30 Quality: CE Certified
Products: Stethoscopes, Forceps (FDA Code: HTD), Helicobacter pylori Urease Test Kits, Endotracheal Tubes, Anesthesia, Antibiotics & Antibacterials, ...
Halyard Health, Inc. is a consumer & medical products company. Its global tissue, personal care and health care brands include Huggies, Pull-Ups, Kotex, Depend, Kleenex, Scott, Kimwipes and WypAll. Ou more...
https://www.halyardhealth.com | Phone: 844-HALYARD (425-9273)
FDA Registration: 3011270181 Year Established: 1903 Annual Revenues: > USD 1 Billion Employee Count: ~30 Quality: CE Certified
Products: Stethoscopes, Forceps (FDA Code: HTD), Helicobacter pylori Urease Test Kits, Endotracheal Tubes, Anesthesia, Antibiotics & Antibacterials, ...
Halyard Health, Inc. is a consumer & medical products company. Its global tissue, personal care and health care brands include Huggies, Pull-Ups, Kotex, Depend, Kleenex, Scott, Kimwipes and WypAll. Ou more...
Hospira, Inc. | Address: 275 N. Field Dr., Lake Forest, Illinois 60045, USA
www.hospira.com | Send Inquiry | Phone: +1-(224)-212-2000
FDA Registration: 1925262 Year Established: 1930 Annual Revenues: > USD 1 Billion Employee Count: ~16000 Quality: ISO 9002 Certified
Products: Anesthesia Equipment, Irrigating Solutions, Pulmonary Artery Catheters, Anesthetics, Antibiotics, Aspirators, ...
Hospira, Inc. focuses on medication delivery systems & critical care devices, which include the next-generation patient-controlled analgesia device, lifeCare PCA®, the plum A+® multichannel in more...
www.hospira.com | Send Inquiry | Phone: +1-(224)-212-2000
FDA Registration: 1925262 Year Established: 1930 Annual Revenues: > USD 1 Billion Employee Count: ~16000 Quality: ISO 9002 Certified
Products: Anesthesia Equipment, Irrigating Solutions, Pulmonary Artery Catheters, Anesthetics, Antibiotics, Aspirators, ...
Hospira, Inc. focuses on medication delivery systems & critical care devices, which include the next-generation patient-controlled analgesia device, lifeCare PCA®, the plum A+® multichannel in 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...
Bird & Cronin Inc. | Address: 1200 Trapp Road, Eagan, Minnesota 55121, USA
www.birdcronin.com | Send Inquiry | Phone: +1-(800)-328-1095
FDA Registration: 2182345
Products: Splints, Cast Boots, Ankle Braces, Foot Braces, Shoulder Braces, Knee Braces, ...
Bird and Cronin Inc. manufactures patient footwear, orthopedic soft goods and specialty patient care products. We offer products like cervical, upper extremities, lumbar/low back, lower extremities, c more...
www.birdcronin.com | Send Inquiry | Phone: +1-(800)-328-1095
FDA Registration: 2182345
Products: Splints, Cast Boots, Ankle Braces, Foot Braces, Shoulder Braces, Knee Braces, ...
Bird and Cronin Inc. manufactures patient footwear, orthopedic soft goods and specialty patient care products. We offer products like cervical, upper extremities, lumbar/low back, lower extremities, c more...
Uni-Patch | Address: 1313 West Grant Boulevard, Wabasha, Minnesota 55981, USA
www.uni-patch.com | Send Inquiry | Phone: +1-(651)-565-2601, (800)-328-9454
FDA Registration: 2183164 Year Established: 1978 Employee Count: ~250 Quality: ISO 9000, ISO 9001, ISO 9002, ISO 9003, CE Certified
Products: Electrodes - Disposable, Medical Ultrasound Transmission Gels, Electrodes, Ultrasound Gel, Reusable Bar Electrodes, Medical Adhesive Tape Removers, Electrodes, Reusable, ...
Uni-Patch is a manufacturer of stimulating electrodes. We are FDA registered and ISO 13485 certified. Our product list comprises of electrodes, batteries, adaptors, belts, unit testers, skin care prod more...
www.uni-patch.com | Send Inquiry | Phone: +1-(651)-565-2601, (800)-328-9454
FDA Registration: 2183164 Year Established: 1978 Employee Count: ~250 Quality: ISO 9000, ISO 9001, ISO 9002, ISO 9003, CE Certified
Products: Electrodes - Disposable, Medical Ultrasound Transmission Gels, Electrodes, Ultrasound Gel, Reusable Bar Electrodes, Medical Adhesive Tape Removers, Electrodes, Reusable, ...
Uni-Patch is a manufacturer of stimulating electrodes. We are FDA registered and ISO 13485 certified. Our product list comprises of electrodes, batteries, adaptors, belts, unit testers, skin care prod more...
Oemedic International, Inc. | Address: No. 162, Atlantic Street, Pomona, California 91768, USA
Phone: +1-(886)-2-22903959
Products: Massagers, Direct Patient Interface Nebulizer (FDA Code: CAF), Manual Emergency Ventilator/Resuscitator (FDA Code: BTM), Operating Room Scrub Brush (FDA Code: GEC), Manual Therapeutic Massager (FDA Code: LYG), Powered Heating Pad (FDA Code: IRT), ...
Oemedic International, Inc. manufactures manual emergency ventilator and manual therapeutic massager. more...
Phone: +1-(886)-2-22903959
Products: Massagers, Direct Patient Interface Nebulizer (FDA Code: CAF), Manual Emergency Ventilator/Resuscitator (FDA Code: BTM), Operating Room Scrub Brush (FDA Code: GEC), Manual Therapeutic Massager (FDA Code: LYG), Powered Heating Pad (FDA Code: IRT), ...
Oemedic International, Inc. manufactures manual emergency ventilator and manual therapeutic massager. more...
Advanced Materials, Inc. | Address: 20211 South Susana Rd., Rancho Dominguez, California 90221, USA
www.advancedmaterials.net | Send Inquiry | Phone: +1-(310)-537-5444, (800) 395.3626
FDA Registration: 2020678 Quality: ISO 13485 certified Certified
Products: Foley Catheter Holders (FDA Code: EYJ), Ice Bags (FDA Code: KYR), Cautery Tip Cleaner, Ureteral Catheter Holder (FDA Code: EYJ), Scintillation Gamma Camera (FDA Code: IYX), Mammographic X-Ray System (FDA Code: IZH), ...
Advanced Materials, Inc. develops a range of medical products. We offer die cut foam, heat sonic sealed and pressure sensitive adhesive products. The die cut foam products are foam pads for endoscopic more...
www.advancedmaterials.net | Send Inquiry | Phone: +1-(310)-537-5444, (800) 395.3626
FDA Registration: 2020678 Quality: ISO 13485 certified Certified
Products: Foley Catheter Holders (FDA Code: EYJ), Ice Bags (FDA Code: KYR), Cautery Tip Cleaner, Ureteral Catheter Holder (FDA Code: EYJ), Scintillation Gamma Camera (FDA Code: IYX), Mammographic X-Ray System (FDA Code: IZH), ...
Advanced Materials, Inc. develops a range of medical products. We offer die cut foam, heat sonic sealed and pressure sensitive adhesive products. The die cut foam products are foam pads for endoscopic more...
BREG, Inc | Address: 2611 Commerce Way, Vista, California 92081, USA
www.breg.com | Send Inquiry | Phone: +1-(760)-599-3000/800-321-0607
FDA Registration: 2028253 Year Established: 1989
Products: Ankle Braces, Walkers, Back Braces & Supports, Crutches, Canes, Walkers, Ankle and Foot Braces, Ankle Braces & Supports, ...
BREG, Inc provides premium orthopedic, reconstructive and postoperative products. We offer orthopedic bracing, pain management, cold therapy and continuous passive motion. Our extensive product offers more...
www.breg.com | Send Inquiry | Phone: +1-(760)-599-3000/800-321-0607
FDA Registration: 2028253 Year Established: 1989
Products: Ankle Braces, Walkers, Back Braces & Supports, Crutches, Canes, Walkers, Ankle and Foot Braces, Ankle Braces & Supports, ...
BREG, Inc provides premium orthopedic, reconstructive and postoperative products. We offer orthopedic bracing, pain management, cold therapy and continuous passive motion. Our extensive product offers more...
DJO Incorporated | Address: 1430 Decision Street, Vista, California 92081-8553, USA
www.djoglobal.com | Phone: +1-(760)-727-1280, 800-336-6569
FDA Registration: 2020737 Year Established: 1978 Employee Count: ~4000
Products: Ankle Braces, Knee Braces, Cuffing System, Orthopedic knee Braces, Orthopaedic Implants, Ankle Braces & Supports, ...
DJO Incorporated is a provider of orthopedic devices. We offer a wide range of products used for rehabilitation, pain management and physical therapy. We also develop, manufacture and distribute a bro more...
www.djoglobal.com | Phone: +1-(760)-727-1280, 800-336-6569
FDA Registration: 2020737 Year Established: 1978 Employee Count: ~4000
Products: Ankle Braces, Knee Braces, Cuffing System, Orthopedic knee Braces, Orthopaedic Implants, Ankle Braces & Supports, ...
DJO Incorporated is a provider of orthopedic devices. We offer a wide range of products used for rehabilitation, pain management and physical therapy. We also develop, manufacture and distribute a bro more...
Sunbeam Products, Inc. | Address: 2381 Executive Center Dr., Boca Raton, Florida 33431, USA
www.sunbeam.com | Phone: +1-(561)-912-4100
FDA Registration: 1043899
Products: Neonatal Disposable Blood Pressure Cuffs, Body Composition Analyzer (FDA Code: MNW), Ice Bags (FDA Code: KYR), Non-Direct Patient Interface Humidifier (FDA Code: KFZ), Patient Stand-On Scale (FDA Code: FRI), Disposable Hot/Cold Pack (FDA Code: IMD), ...
Sunbeam Products, Inc. offers air conditioners, dehumidifiers, fans, hair care, heaters, heating pads and humidification products. Our mattress pads include heated, quilted heated, waterproof heated a more...
www.sunbeam.com | Phone: +1-(561)-912-4100
FDA Registration: 1043899
Products: Neonatal Disposable Blood Pressure Cuffs, Body Composition Analyzer (FDA Code: MNW), Ice Bags (FDA Code: KYR), Non-Direct Patient Interface Humidifier (FDA Code: KFZ), Patient Stand-On Scale (FDA Code: FRI), Disposable Hot/Cold Pack (FDA Code: IMD), ...
Sunbeam Products, Inc. offers air conditioners, dehumidifiers, fans, hair care, heaters, heating pads and humidification products. Our mattress pads include heated, quilted heated, waterproof heated a more...
Rece International Corp. | Address: 5881 N.W. 151st St., Ste. 111, Miami Lakes, Florida 33014, USA
Phone: +1-(305)-3626555
FDA Registration: 3003965134
Products: Oxygen Masks (FDA Code: BYG), Adult Tongue Depressor (FDA Code: FMA), Hydrophilic Wound Dressings (FDA Code: NAC), Blood Collection Lancet (FDA Code: FMK), Emesis Basin (FDA Code: FNY), Elastic Stocking (FDA Code: ILG), ...
Rece International Corp. provides surgical and medical equipments such as adult tongue depressors, blood collection lancets, elastic stockings, emesis basins, hydrophilic wound dressings, venturi low more...
Phone: +1-(305)-3626555
FDA Registration: 3003965134
Products: Oxygen Masks (FDA Code: BYG), Adult Tongue Depressor (FDA Code: FMA), Hydrophilic Wound Dressings (FDA Code: NAC), Blood Collection Lancet (FDA Code: FMK), Emesis Basin (FDA Code: FNY), Elastic Stocking (FDA Code: ILG), ...
Rece International Corp. provides surgical and medical equipments such as adult tongue depressors, blood collection lancets, elastic stockings, emesis basins, hydrophilic wound dressings, venturi low more...
Bruder Healthcare Company | Address: 3150 Engineering Parkway, Alpharetta, Georgia 30004, USA
www.bruder.com | Send Inquiry | Phone: +1-(770)-569-5994, 888-827-8337
FDA Registration: 1039131 Year Established: 1986 Annual Revenues: USD 1-5 Million Employee Count: ~10
Products: Moist Heat Therapy Equipment, Heat Therapy Pads, Ice Bags (FDA Code: KYR), Pain Relief Spray, Cold Pads, Cold/Heat Wraps, ...
Bruder Healthcare Company specializes in providing safe & effective doctor recommended moist heat and cold therapy products designed to meet the needs of pain sufferers seeking natural pain relief. We more...
www.bruder.com | Send Inquiry | Phone: +1-(770)-569-5994, 888-827-8337
FDA Registration: 1039131 Year Established: 1986 Annual Revenues: USD 1-5 Million Employee Count: ~10
Products: Moist Heat Therapy Equipment, Heat Therapy Pads, Ice Bags (FDA Code: KYR), Pain Relief Spray, Cold Pads, Cold/Heat Wraps, ...
Bruder Healthcare Company specializes in providing safe & effective doctor recommended moist heat and cold therapy products designed to meet the needs of pain sufferers seeking natural pain relief. We more...
C. R. Bard, Inc., Bard Medical Div. | Address: 8195 Industrial Blvd., Covington, Georgia 30209, USA
www.bardmedical.com | Send Inquiry | Phone: +1-(770)-784-6100, 800-526-4455
FDA Registration: 3006082230 Quality: ISO 9001 Certified
Products: Arthroscopes (FDA Code: HRX), Adhesive Bandages (FDA Code: KGX), Autotransfusion Apparatus (FDA Code: CAC), Active Electrosurgical Electrode (FDA Code: FAS), AV Shunt Accessories (FDA Code: KNZ), Anti-Infective Latex Foley Catheters, ...
C. R. Bard, Inc., Bard Medical Div. provides products and services that meet the needs of healthcare providers & patients. We specialize in disease state management offering the industry's comprehensi more...
www.bardmedical.com | Send Inquiry | Phone: +1-(770)-784-6100, 800-526-4455
FDA Registration: 3006082230 Quality: ISO 9001 Certified
Products: Arthroscopes (FDA Code: HRX), Adhesive Bandages (FDA Code: KGX), Autotransfusion Apparatus (FDA Code: CAC), Active Electrosurgical Electrode (FDA Code: FAS), AV Shunt Accessories (FDA Code: KNZ), Anti-Infective Latex Foley Catheters, ...
C. R. Bard, Inc., Bard Medical Div. provides products and services that meet the needs of healthcare providers & patients. We specialize in disease state management offering the industry's comprehensi more...
Bagco | Address: 1650 Airport Road Suite 104, Kennesaw, Georgia 30144, USA
www.bagco.com | Send Inquiry | Phone: +1-(770)-422-4187, 800-533-1931
Annual Revenues: USD 5-10 Million Employee Count: ~30 Quality: ISO 9000, ISO 9002 Certified
Products: Ice Bags (FDA Code: KYR), Inert Plastic Bags, Lab Specimen Transport Bags, Specimen Collection Device (FDA Code: LIO), Plastic Bag, Specimen Bags, ...
Bagco offers plastic reclosable packaging for pharmaceuticals, hospital and health care markets. Our products include TearZone® specimen transport and medical Zippit&Reg; bags. The TearZone has no more...
www.bagco.com | Send Inquiry | Phone: +1-(770)-422-4187, 800-533-1931
Annual Revenues: USD 5-10 Million Employee Count: ~30 Quality: ISO 9000, ISO 9002 Certified
Products: Ice Bags (FDA Code: KYR), Inert Plastic Bags, Lab Specimen Transport Bags, Specimen Collection Device (FDA Code: LIO), Plastic Bag, Specimen Bags, ...
Bagco offers plastic reclosable packaging for pharmaceuticals, hospital and health care markets. Our products include TearZone® specimen transport and medical Zippit&Reg; bags. The TearZone has no more...
LDB Medical, Inc. | Address: 2909 Langford Road, Suite 500-B, Norcross, Georgia 30071, USA
www.ldbmedical.com | Send Inquiry | Phone: +1-(770)-446-2554, 800-243-2554
Year Established: 1990 Annual Revenues: < USD 1 Million
Products: Reusable Latex Leg Bag, Wheelchair Accessories (FDA Code: KNO), Ice Bags (FDA Code: KYR), Ankle Support, Disposable Bedpads, Patient Aids, ...
LDB Medical, Inc. is a single source supplier of patient aids, self-help devices, incontinence, urological supplies, ostomy and wheelchair accessories. Our product list comprises of adhesive remover, more...
www.ldbmedical.com | Send Inquiry | Phone: +1-(770)-446-2554, 800-243-2554
Year Established: 1990 Annual Revenues: < USD 1 Million
Products: Reusable Latex Leg Bag, Wheelchair Accessories (FDA Code: KNO), Ice Bags (FDA Code: KYR), Ankle Support, Disposable Bedpads, Patient Aids, ...
LDB Medical, Inc. is a single source supplier of patient aids, self-help devices, incontinence, urological supplies, ostomy and wheelchair accessories. Our product list comprises of adhesive remover, more...
Patterson Medical Products, Inc. | Address: 1000 Remington Blvd., Suite 210, Bolingbrook, Illinois 60440-5117, USA
www.sammonspreston.com | Send Inquiry | Phone: +001-(630)-378-6000
Year Established: 1977 Annual Revenues: USD 50-100 Million Employee Count: ~20
Products: Splints, Forceps (FDA Code: HTD), Scissors, Adhesive Surgical Paper, Exercise Boards, Casting Materials, ...
Sammons Preston manufactures forceps, exercise boards, orthopedics, pediatrics, sensory motor, goniometers and Knee/Ankle braces & supports. Our turtle therapy system is an economical package designed more...
www.sammonspreston.com | Send Inquiry | Phone: +001-(630)-378-6000
Year Established: 1977 Annual Revenues: USD 50-100 Million Employee Count: ~20
Products: Splints, Forceps (FDA Code: HTD), Scissors, Adhesive Surgical Paper, Exercise Boards, Casting Materials, ...
Sammons Preston manufactures forceps, exercise boards, orthopedics, pediatrics, sensory motor, goniometers and Knee/Ankle braces & supports. Our turtle therapy system is an economical package designed more...
Tetra Medical Supply Corporation | Address: 6364 West Gross Point Road, Niles, Illinois 60714, USA
www.tetramed.com | Send Inquiry | Phone: +1-(847)-647-0590, 800-621-4041
FDA Registration: 1418270 Year Established: 1913 Annual Revenues: USD 1-5 Million Employee Count: ~10 Quality: CE Certified
Products: General Medical Supplies, Wrist/Arm/Shoulder Braces & Supports, Adhesive Bandages (FDA Code: KGX), Adhesive Dressing, Bariatric Abdominal Binder, Panel Elastic Abdominal Binder, ...
Tetra Medical Supply Corporation focuses on bandages, dressings, orthopedic softgoods, and hot & cold therapy products. Our portfolio of customers includes hospitals, surgeons, podiatrists, chiropract more...
www.tetramed.com | Send Inquiry | Phone: +1-(847)-647-0590, 800-621-4041
FDA Registration: 1418270 Year Established: 1913 Annual Revenues: USD 1-5 Million Employee Count: ~10 Quality: CE Certified
Products: General Medical Supplies, Wrist/Arm/Shoulder Braces & Supports, Adhesive Bandages (FDA Code: KGX), Adhesive Dressing, Bariatric Abdominal Binder, Panel Elastic Abdominal Binder, ...
Tetra Medical Supply Corporation focuses on bandages, dressings, orthopedic softgoods, and hot & cold therapy products. Our portfolio of customers includes hospitals, surgeons, podiatrists, chiropract more...
Mabis DMI Healthcare | Address: 1931 Norman Drive, Waukegan, Illinois 60085, USA
www.mabis.net | Send Inquiry | Phone: +1-(800)-526-4753
FDA Registration: 1422443 Year Established: 1992 Annual Revenues: USD 25-50 Million
Products: Stethoscopes, Thermometers, Bowls & Basins, Disposable Syringes, EKG Supplies, Aspirators, ...
Mabis DMI Healthcare manufactures nebulizers, blood pressure monitors & thermometers. Our 10-second digital thermometer displays temperature measurements within 10-seconds and cleans easily. Our mist more...
www.mabis.net | Send Inquiry | Phone: +1-(800)-526-4753
FDA Registration: 1422443 Year Established: 1992 Annual Revenues: USD 25-50 Million
Products: Stethoscopes, Thermometers, Bowls & Basins, Disposable Syringes, EKG Supplies, Aspirators, ...
Mabis DMI Healthcare manufactures nebulizers, blood pressure monitors & thermometers. Our 10-second digital thermometer displays temperature measurements within 10-seconds and cleans easily. Our mist more...
Cramer Products, Inc. | Address: PO Box 1001, Gardner, Kansas 66030, USA
www.cramersportsmed.com | Send Inquiry | Phone: +1-(800)-345-2231
FDA Registration: 1910082 Annual Revenues: < USD 1 Million Employee Count: ~80
Products: Splints, Scissors, Adhesive Cloth, Adhesive Elastic, Analgesics, Anesthetics, ...
Cramer Products, Inc. deals with sports medicine. Our Slimeline™ volleyball kneepads are built to provide maximum protection and a minimal fit. The ergonomic winged design wraps comfortably arou more...
www.cramersportsmed.com | Send Inquiry | Phone: +1-(800)-345-2231
FDA Registration: 1910082 Annual Revenues: < USD 1 Million Employee Count: ~80
Products: Splints, Scissors, Adhesive Cloth, Adhesive Elastic, Analgesics, Anesthetics, ...
Cramer Products, Inc. deals with sports medicine. Our Slimeline™ volleyball kneepads are built to provide maximum protection and a minimal fit. The ergonomic winged design wraps comfortably arou more...
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FDA Code / Regulation: KYR / 880.6050
An ice bag is a device intended for medical purposes that is in the form of a container intended to be filled with ice that is used to apply dry cold therapy to an area of the body. The device may include a holder that keeps the bag in place against an external area of the patient.
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.
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