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Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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Silver collagen wound gel (42 g tube) is a medical hydrolysate of collagen with silver oxide. OTC for minor burns, superficial cuts, lacerations, abrasions, irritations of the skin. RX for partial and full thickness wounds. Store at controlled room temperature. Silver oxide controls the growth of microbes that are absorbed into the wound gel. https://dermarite.com/product/silvakollagen-gel/
The Hymed Group Corporation
00500
In Commercial Distribution

  • 00860008336217 ()
  • 00860008336200 ()


  • Animal-derived wound matrix dressing
Silver collagen wound gel (42 g tube) is a medical hydrolysate of collagen with silver oxide. OTC for minor burns, superficial cuts, lacerations, abrasions, irritations of the skin. RX for partial and full thickness wounds. Store at controlled room temperature. Silver oxide controls the growth of microbes that are absorbed into the wound gel. https://dermarite.com/product/silvakollagen-gel/
DERMARITE INDUSTRIES LLC
00500
In Commercial Distribution

  • 01714196500150 ()
  • 00714196500151 ()
00500

  • Animal-derived wound matrix dressing
First Aid Kit containing Medical Devices class I and Drugs OTC: Neomycin Antibiotic, Triangular Bandage, Rescue Blanket, Gauze Compress, Hydrocortisone, Plastic Tweezer, Adhesive Bandage, Antiseptic, Burn Relief, Adhesive Tape, Gauze Clean-wrap Bandage, Gauze Pads, CPR Filter Shield, PVP Pre pads, Buffered Eye Wash, Scissor Bandage, Nitrile gloves, Cold Pack, Eye Pads, Woven Fingertip Bandage, Woven Knuckle Bandage.
North Safety de Mexicali, S. de R. L. de C.V.
018504-4222
In Commercial Distribution

  • 00821812024523 ()


  • First aid kit, medicated
The Comfy Curve Massage Pro device is an electrically powered, vibrating therapeutic massager. The device consists of a memory foam pillow with a small internal motor, powered by (2) AA batteries (not included), that vibrates the entire pillow. The Comfy Curve Massage Pro is an OTC device that is intended to be used on the body for relief of minor aches and pains.
Spark Innovators Corporation
CCPMP-MC3
In Commercial Distribution

  • 20850018026165 ()
  • 00850018026161 ()

  • Width: 18 Inch


  • Hand-held electric massager
Powered heating pad. An assembly of mains electricity (AC-powered) devices designed for the transcutaneous application of heat to a localized body site (e.g., joint, limb) to relieve musculoskeletal pain. It consists of an electric heating pad typically made of synthetic fabric materials, and a hand-held control unit used to regulate and monitor the heat. It is normally available [non-prescription] over-the-counter (OTC) for use in the home.
Hayswell
HP-3000
In Commercial Distribution

  • 00860036001101 ()


  • Electric pad localized-body heating system
PainKARE is an OTC medical device intended to temporarily relieve pain due to strain from exercise or normal household work or activities via electro-therapy. The Device consists two Stimulator pads connected by a USB cable for Electrotherapy.'' PainKARE’s Stimulator pads operate in a programmable micro-current mode and deliver Biphasic waveforms which in turn provide electrical stimulation to the body that aids in relieving pain.
TRIOWAVE TECHNOLOGIES
PK001
In Commercial Distribution

  • 00866946000302 ()


  • Analgesic transcutaneous electrical nerve stimulation system
Professional + All Purpose First Aid Kit: 351 pieces containing medical devices and OTC drugs: burn dressing, cold pack, adhesive bandages, butterfly closure, gauze pads, eye pad, trauma pad, CPR breathing barrier, rolled gauze, cotton swabs, paper tape, finger splint, triangular sling, nitrile gloves, scissors, tweezers, alcohol prep pad, antiseptic wipes, hand sanitizer, eye wash, burn gel, antibiotic ointment, acetaminophen, aspirin, ibuprofen and sting relief wipe.
Aso LLC
B07CGFT1FF
Not in Commercial Distribution

  • 00017276233599 ()
  • 10017276233596 ()

  • 13.0 x 11.75 x 4.25 in
B07CGFT1FF

  • First aid kit, medicated
The NIRA PRO+ is a hand-held reusable OTC non-fractional diode laser device employing 1450 nm wavelength. The NIRA PRO+ consists of a hand piece, wall-plug battery charger, and 1.5 foot USB cable. The hand piece fits in the hand and the laser light comes out of the tip. There is a USB C connector interface that provides battery charging. The NIRA PRO+ is used for treatment of periorbital wrinkles.
Nira Innovations Incorporated
174-000
In Commercial Distribution

  • 00850020752454 ()


  • Dermatological laser beam guiding handpiece
The NIRA Precision Laser is a hand-held reusable OTC non-fractional diode laser device employing 1450 nm wavelength. The NIRA Laser consists of a hand piece and 1.5 foot USB cable. The hand piece fits in the hand and the laser light comes out of the tip. There is a single USB C connector interface that provides battery charging. The NIRA Laser is used for treatment of periorbital wrinkles.
Nira Innovations Incorporated
117-000
In Commercial Distribution

  • 00850020752126 ()


  • Dermatological laser beam guiding handpiece
The NIRA PRO is a hand-held reusable OTC non-fractional diode laser device employing 1450 nm wavelength. The NIRA PRO consists of a hand piece, wall-plug battery charger, and 1.5 foot USB cable. The hand piece fits in the hand and the laser light comes out of the tip. There is a USB C connector interface that provides battery charging. The NIRA PRO is used for treatment of periorbital wrinkles.
Nira Innovations Incorporated
151-000
In Commercial Distribution

  • 00850020752119 ()


  • Dermatological laser beam guiding handpiece
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