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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Lexie B2, Powered by Bose re-chargeable self-fitting hearing aid
HEARX GROUP (PTY) LTD
Lexie B2 Self-fitting OTC Hearing Aids Powered by Bose
In Commercial Distribution

  • 10850022464642 ()
  • 00850022464645 ()
In-Store

  • Air-conduction hearing aid, receiver-in-canal
Lexie B1 Hearing Aids, powered by Bose. Self-fit, app-controlled hearing aids
HEARX GROUP (PTY) LTD
Lexie B1 Self-fitting OTC Hearing Aids Powered by Bose
In Commercial Distribution

  • 00850022464577 ()
  • 10850022464574 ()
In-Store

  • Air-conduction hearing aid, receiver-in-canal
1 TMT® Tourniquet 1 Hemostatic gauze (OTC) 2 Vented chest seal 1 Pre-Lubricated nasal airway 1 Compression dressing 1 Pair Exam gloves 1 Instruction guide
Safeguard US Operating, LLC
01
In Commercial Distribution

  • M6898723101011 ()
87-231-01

  • First aid kit, non-medicated, single-use
The LED Lip Perfector (Model: ZC-05) is an Over-the-Counter (OTC) device intended to treat fine lines and wrinkles and increase in circulation within the perioral region.
Shenzhen Kaiyan Medical Equipment Co,. Ltd
ZC-05
In Commercial Distribution

  • 00655729008426 ()


  • Cosmetic red-light phototherapy system, home-use
OTC hearing aids, behind-the-ear micro design, 4 preset hearing modes, 11 volume levels, with rechargeable lithium battery, charging case and power adapter included, IP22 water resistant.
Voxx Accessories Corp.
RSH072GY
In Commercial Distribution

  • 00044476158483 ()


  • Air-conduction hearing aid, behind-the-ear
OTC hearing aids, in-canal design, 4 pre-programmed environment modes + 6 volume levels with active noise reduction, built-in rechargeable lithium battery, charging case and power adapter included.
Voxx Accessories Corp.
RSH30BG
In Commercial Distribution

  • 00044476157523 ()


  • Air-conduction hearing aid, canal
Bluetooth-enabled wireless OTC hearing aids, behind-the-ear design, 4 preset hearing modes, IP54 water resistant, with built-in rechargeable lithium battery, keychain remote, charging case and power adapter included.
Voxx Accessories Corp.
RSH082GM
In Commercial Distribution

  • 00044476158605 ()


  • Air-conduction hearing aid, receiver-in-canal
First Aid Kit containing Medical Devices Class I and Drugs OTC: Ammonia Inhalants, Gauze Bandage, Triangular Bandage, Adhesive Tape, Bandage Compress, Burn Ointment, PVP wipes, Nitrile gloves, Scissors angled.
North Safety de Mexicali, S. de R. L. de C.V.
010998-4407
In Commercial Distribution

  • 00821812033785 ()


  • First aid kit, medicated
Barrier Bandage it’s intended to contain post-injection bleeding during a subcutaneous or intramuscular injection. The device is intended for healthcare professions (HCP) and lay users. The device is an OTC product.
HTL STREFA S A
n/a
In Commercial Distribution

  • 15907996099976 ()
  • 05907996099979 ()
  • 85907996099975 ()
6070

  • Skin adhesive protective material
First Aid Kit containing Medical Devices class I and Drugs OTC: Triple Antibiotic, Triangular Bandage, Gauze Pads, Adhesive Tape, Gauze Compress, Cold Pack, Adhesive Bandage, PVP Iodine Wipes, Nitrile Gloves, Scissor Bandage.
North Safety de Mexicali, S. de R. L. de C.V.
019709-0005L
In Commercial Distribution

  • 00821812025193 ()


  • First aid kit, medicated
First Aid Kit containing Drugs OTC and Medical Devices class I: Woven, Adhesive tape, Nitrile Gloves, Antiseptic Towelettes, Survival Blanket, Scissor bandage, Splinter Forceps, Bandage compress, CPR Mask, Triangular bandage, Gauze pads.
North Safety de Mexicali, S. de R. L. de C.V.
SF00001996
In Commercial Distribution

  • 00883940051529 ()


  • First aid kit, medicated
First Aid kit containing Medical Devices class I and Drugs OTC: First Aid Burn cream, Ammonia Inhalants, Triangular bandage, Gauze pads, Forceps & Scissors, Gauze Bandage, Buffered eye wash, Alcohol pre pads, Adhesive Tape.
North Safety de Mexicali, S. de R. L. de C.V.
010742-3236
In Commercial Distribution

  • 00821812040714 ()


  • First aid kit, medicated
Avenova OTC is a clear liquid solution cleanser composed of hypochlorous acid (HOCl) 0.01% in saline. The solution is provided in a glass bottle with a pump provided for use in spraying the solution.
NOVABAY PHARMACEUTICALS, INC.
NBY 101-6
In Commercial Distribution

  • 00857005004232 ()
NBY 101-6

  • Antimicrobial wound irrigation solution
First Aid Kit containing Medical Devices class I and Drugs OTC: First Aid Burn cream, Ammonia Inhalants, Gauze Bandage, Triangular Bandage, Adhesive Tape, Bandage Compress, Adhesive bandage, PVP Iodine wipes, Scissor bandage, Nitrile gloves.
North Safety de Mexicali, S. de R. L. de C.V.
011798-1494
In Commercial Distribution

  • 00821812024462 ()


  • First aid kit, medicated
Ora-GUARD is an OTC device worn on the teeth while sleeping, intended to protect the teeth and reduce damage caused by bruxing or nighttime grinding and prevention of the noise associated with bruxing and grinding.
Doc Brands, Inc.
1
In Commercial Distribution

  • 00816161015131 ()


  • Removable dental occlusal splint, customizable
First Aid Kit containing Medical Devices class I and Drug OTC: Plastic Tweezer, PVP Pre Pads, Nitrile gloves, First Aid cream, Adhesive Tape, Neomycin Antibiotic, Cold Pack, Gauze Pads, Woven Fingertip Bandage, Woven Knuckle Bandage.
North Safety de Mexicali, S. de R. L. de C.V.
018503-4219
In Commercial Distribution

  • 00821812020976 ()


  • First aid kit, medicated
First Aid Kit containing Medical Devices Class I and Drugs OTC: Plastic Bandage, Tweezer, Gauze Clean-Wrap Bandage, Scissor Bandage, Nitrile Gloves, Tape Adhesive, Triangular Bandage, Eye Pad, Gauze Pads, Antiseptic Wipes, First Aid Cream, Neomycin Antibiotic.
North Safety de Mexicali, S. de R. L. de C.V.
010101-4354L
In Commercial Distribution

  • 00821812021270 ()


  • First aid kit, medicated
The Sunny Cup and Applicator is an OTC device indicated for use as a receptacle placed in the vagina to collect menstrual fluid and cellular debris that is extruded from the uterus via the cervix during menstruation.
Sunny
SUNAC011PEGI01
In Commercial Distribution

  • 00860009638617 ()


  • Menstrual cup, non-latex, reusable
First Aid Kit containing Medical Devices class I and Drugs OTC: Knuckle bandage, Ammonia Inhalants, Triangular Bandage, Gauze compress, Bandage Compress, Adhesive Bandage, Fingertip Bandage, Buffered Eye wash, Burn Jel, PVP Iodine wipes, Nox A Sting wipes and Tourniquet.
North Safety de Mexicali, S. de R. L. de C.V.
010875-0349
In Commercial Distribution

  • 00821812040752 ()


  • First aid kit, medicated
First Aid Kit containing Medical Devices class I and Drugs OTC: Knuckle band, Triangular Bandage, Gauze Pads, Adhesive Tape, Gauze Compress, Cold Pack, Buffered Eye Wash, Bandage Compress, Adhesive Bandage, PVP Iodine Wipes, Nitrile Gloves, Micro shield, Nox A Sting Wipes.
North Safety de Mexicali, S. de R. L. de C.V.
013087-1725A
In Commercial Distribution

  • 00821812046778 ()


  • First aid kit, medicated
First Aid Kit containing Medical Devices class I and Drugs OTC: Gauze Bandage, Triangular Bandage, Gauze Pads, Adhesive Tape, Cold Pack, Eye wash, Adhesive Bandage, Burn Jel, Biohazard bag, Nitrile gloves, Antimicrobial Towelettes, CPR Micro shield, Nox A Sting wipes.
North Safety de Mexicali, S. de R. L. de C.V.
010019-4320
In Commercial Distribution

  • 00821812042237 ()


  • First aid kit, medicated
First Aid Kit containing Medical Devices class I and Drugs OTC: Neomycin antibiotic, Triangular Bandage, Gauze Pads, Adhesive Tape, Cold Pack, Bandage compress, Adhesive Bandage, Burn Jel, Biohazard bag, Nitrile gloves, Antimicrobial antiseptic towelettes, Buffered Eye wash, Nox A Sting Wipes.
North Safety de Mexicali, S. de R. L. de C.V.
011007-4330
In Commercial Distribution

  • 00821812040790 ()


  • First aid kit, medicated
Repair-it is an OTC denture repair kit for home use. The device consists of a material, such as a resin monomer system of powder and liquid glues, that is intended to be applied permanently to a denture to mend cracks or breaks.
Doc Brands, Inc.
1
In Commercial Distribution

  • 00372494101915 ()


  • Denture repair kit, home-use
First Aid Kit containing Medical Devices class I and Drugs OTC: Neomycin Antibiotic, Triangular Bandage, Gauze Pads, Adhesive Tape, Rescue Blanket, Bandage Compress, Adhesive Bandage, Burn Jel, Biohazard bag, Adhesive Bandage, Nitrile gloves, Antimicrobial Antiseptic Towelettes, Buffered Eye wash, Nox A Sting Wipes.
North Safety de Mexicali, S. de R. L. de C.V.
011008-4331
In Commercial Distribution

  • 00821812040813 ()


  • First aid kit, medicated
First Aid kit containing Medical Devices Class I and Drugs OTC: Gauze Pads, Tweezer Plastics, Gauze clean-wrap, CPR Filter shield, Bandage Compressed, Scissor Bandage, Nitrile Gloves, Plastic Bands, Tape Adhesive, Triangular Bandage, Eye Pads, Woven Fingertip Bandage, Woven Knuckle Bandage, Eye saline.
North Safety de Mexicali, S. de R. L. de C.V.
019702-0002L
In Commercial Distribution

  • 00821812025070 ()


  • First aid kit, medicated
SWAT-TORG SWAT-T Tourniquet, Orange 30-212 MARCH Celox Rapid B-CON 3"x2' OTC HVS01 H*VENT Vented Chest Seal, Single HHMCB01 Mini-Compression Bandage (Sterile) - 4" x 6" abdominal pad GLOVES-2.00.101 Synmax, Blue, Industrial Grade, Powered Free, Latex Free L01-002 2X4WHITE BLANK LABEL P88-100 Pouch, 6X12-LE Kit
Safeguard US Operating, LLC
1
In Commercial Distribution

  • M689HHECTK010 ()
HHECTK-01

  • Pressure bandage, non-latex, single-use
● It is intended for temporary relief of pain associated with sore and aching muscles in the low back as well as upper and lower extremities (arm and/or leg) due to strain from exercise or normal household and work activities. ● OTC TENS, Patch type.
WELL-LIFE HEALTHCARE LTD.
WL-2406
Not in Commercial Distribution

  • 04719872264064 ()


  • Physical therapy transcutaneous electrical stimulation system, line-powered
OTC Mini Patch, models: WL-2301A & WL-2301B Transcutaneous Electrical Nerve Stimulators and intended for temporary relief of pain associated with sore and aching muscles in the upper and lower extremities (arm and/or leg) due to strain from exercise or normal household and work activities.
WELL-LIFE HEALTHCARE LTD.
WL-2301
Not in Commercial Distribution

  • 04719872263012 ()


  • Physical therapy transcutaneous electrical stimulation system, line-powered
First Aid kit containing Drugs OTC and Medical Devices class I: Tweezer Plastic, Gauze clean-wrap bandage, Scissor bandage, Nitrile gloves, Plastics bands, Adhesive Tape, Adhesive Bandage, Triangular bandage, Cold Pack, Gauze Pads, Woven Fingertip, Antiseptic wipes, First Aid cream, Neomycin, Sting relief wipes, Aypanal.
North Safety de Mexicali, S. de R. L. de C.V.
019700-4500F
In Commercial Distribution

  • 00821812400921 ()


  • First aid kit, medicated
Adhesive electrodes are intended for use as the disposable, conductive adhesive interface between the patient’s skin and the Electrical Stimulator. Adhesive Electrodes are intended to be used with marketed Electrical Stimulators, i.e. TENS (Transcutaneous Electrical Nerve Stimulation) and EMS (Electrical Muscular Stimulation). It is for OTC use.
Shenzhen Yuwen E-Commerce Co., Ltd.
EB1524022
In Commercial Distribution

  • 16971292005251 ()
  • 06971292005247 ()
  • 16971292005244 ()


  • Transcutaneous electrical stimulation electrode, single-use
Adhesive electrodes are intended for use as the disposable, conductive adhesive interface between the patient’s skin and the Electrical Stimulator. Adhesive Electrodes are intended to be used with marketed Electrical Stimulators, i.e. TENS (Transcutaneous Electrical Nerve Stimulation) and EMS (Electrical Muscular Stimulation). It is for OTC use.
Shenzhen Yuwen E-Commerce Co., Ltd.
EB1508022
In Commercial Distribution

  • 06971292005087 ()
  • 16971292005091 ()
  • 16971292005084 ()


  • Transcutaneous electrical stimulation electrode, single-use
Adhesive electrodes are intended for use as the disposable, conductive adhesive interface between the patient’s skin and the Electrical Stimulator. Adhesive Electrodes are intended to be used with marketed Electrical Stimulators, i.e. TENS (Transcutaneous Electrical Nerve Stimulation) and EMS (Electrical Muscular Stimulation). It is for OTC use.
Shenzhen Yuwen E-Commerce Co., Ltd.
Red0510
In Commercial Distribution

  • 16971292002465 ()
  • 06971292002468 ()


  • Transcutaneous electrical stimulation electrode, single-use
Adhesive electrodes are intended for use as the disposable, conductive adhesive interface between the patient’s skin and the Electrical Stimulator. Adhesive Electrodes are intended to be used with marketed Electrical Stimulators, i.e. TENS (Transcutaneous Electrical Nerve Stimulation) and EMS (Electrical Muscular Stimulation). It is for OTC use.
Shenzhen Yuwen E-Commerce Co., Ltd.
Red0505
In Commercial Distribution

  • 16971292002458 ()
  • 06971292002451 ()


  • Transcutaneous electrical stimulation electrode, single-use
Adhesive electrodes are intended for use as the disposable, conductive adhesive interface between the patient’s skin and the Electrical Stimulator. Adhesive Electrodes are intended to be used with marketed Electrical Stimulators, i.e. TENS (Transcutaneous Electrical Nerve Stimulation) and EMS (Electrical Muscular Stimulation). It is for OTC use.
Shenzhen Yuwen E-Commerce Co., Ltd.
AS040401
In Commercial Distribution

  • 06971292002444 ()


  • Transcutaneous electrical stimulation electrode, single-use
Adhesive electrodes are intended for use as the disposable, conductive adhesive interface between the patient’s skin and the Electrical Stimulator. Adhesive Electrodes are intended to be used with marketed Electrical Stimulators, i.e. TENS (Transcutaneous Electrical Nerve Stimulation) and EMS (Electrical Muscular Stimulation). It is for OTC use.
Shenzhen Yuwen E-Commerce Co., Ltd.
EB2524023
In Commercial Distribution

  • 16971292006258 ()
  • 06971292006244 ()
  • 16971292006241 ()


  • Transcutaneous electrical stimulation electrode, single-use
Adhesive electrodes are intended for use as the disposable, conductive adhesive interface between the patient’s skin and the Electrical Stimulator. Adhesive Electrodes are intended to be used with marketed Electrical Stimulators, i.e. TENS (Transcutaneous Electrical Nerve Stimulation) and EMS (Electrical Muscular Stimulation). It is for OTC use.
Shenzhen Yuwen E-Commerce Co., Ltd.
EP3M12
In Commercial Distribution

  • 16971292003073 ()
  • 06971292003076 ()


  • Transcutaneous electrical stimulation electrode, single-use
Adhesive electrodes are intended for use as the disposable, conductive adhesive interface between the patient’s skin and the Electrical Stimulator. Adhesive Electrodes are intended to be used with marketed Electrical Stimulators, i.e. TENS (Transcutaneous Electrical Nerve Stimulation) and EMS (Electrical Muscular Stimulation). It is for OTC use.
Shenzhen Yuwen E-Commerce Co., Ltd.
EP2M04
In Commercial Distribution

  • 16971292002861 ()
  • 06971292002864 ()


  • Transcutaneous electrical stimulation electrode, single-use
Adhesive electrodes are intended for use as the disposable, conductive adhesive interface between the patient’s skin and the Electrical Stimulator. Adhesive Electrodes are intended to be used with marketed Electrical Stimulators, i.e. TENS (Transcutaneous Electrical Nerve Stimulation) and EMS (Electrical Muscular Stimulation). It is for OTC use.
Shenzhen Yuwen E-Commerce Co., Ltd.
EP2608
In Commercial Distribution

  • 16971292002854 ()
  • 06971292002857 ()


  • Transcutaneous electrical stimulation electrode, single-use
Adhesive electrodes are intended for use as the disposable, conductive adhesive interface between the patient’s skin and the Electrical Stimulator. Adhesive Electrodes are intended to be used with marketed Electrical Stimulators, i.e. TENS (Transcutaneous Electrical Nerve Stimulation) and EMS (Electrical Muscular Stimulation). It is for OTC use.
Shenzhen Yuwen E-Commerce Co., Ltd.
EP2704
In Commercial Distribution

  • 16971292002847 ()
  • 06971292002840 ()


  • Transcutaneous electrical stimulation electrode, single-use
Adhesive electrodes are intended for use as the disposable, conductive adhesive interface between the patient’s skin and the Electrical Stimulator. Adhesive Electrodes are intended to be used with marketed Electrical Stimulators, i.e. TENS (Transcutaneous Electrical Nerve Stimulation) and EMS (Electrical Muscular Stimulation). It is for OTC use.
Shenzhen Yuwen E-Commerce Co., Ltd.
EB1520
In Commercial Distribution

  • 16971292002564 ()
  • 06971292002567 ()


  • Transcutaneous electrical stimulation electrode, single-use
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