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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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First Aid Kit containing Medical Devices class I and Drugs OTC: Knuckle Bandage, Triple Antibiotic, First Aid Burn cream, Triangular Bandage, Gauze Pads, Adhesive Tape, Forceps, Scissor, Gauze Bandage, Gauze Compress, Cold Pack, Buffered Eyewash, Bandage compress, Adhesive Bandage, Fingertip Bandage, PVP Iodine wipes, Nitrile gloves.
North Safety de Mexicali, S. de R. L. de C.V.
019713-0007L
In Commercial Distribution

  • 00821812025278 ()


  • First aid kit, medicated
First Aid Kit containing Medical Devices class I and Drugs OTC: Knuckle Band, Triple Antibiotic, First Aid Burn Cream, Triangular Bandage, Gauze Pads, Adhesive Tape, Forceps, Scissors, Gauze compress, Cold Pack, Buffered Eye wash, Bandage compress, Adhesive Bandage, PVP Iodine wipes, Nitrile Gloves, Nox A Sting Wipes.
North Safety de Mexicali, S. de R. L. de C.V.
019710-0006L
In Commercial Distribution

  • 00821812025216 ()


  • First aid kit, medicated
Prescription Use - The Axiostat Gauze is intended for use as a temporary external dressing to control moderate to severe bleeding and manage external abrasions, lacerations. OTC Use - The Axiostat Gauze is indicated for the local management of bleeding wounds such as minor cuts, lacerations, and abrasions.
AXIO BIOSOLUTIONS PRIVATE LIMITED
AG4010
Not in Commercial Distribution

  • 08600087686740 ()


  • Chitosan haemostatic agent, professional, non-bioabsorbable
Prescription Use - The Axiostat Gauze is intended for use as a temporary external dressing to control moderate to severe bleeding and manage external abrasions, lacerations. OTC Use - The Axiostat Gauze is indicated for the local management of bleeding wounds such as minor cuts, lacerations, and abrasions.
AXIO BIOSOLUTIONS PRIVATE LIMITED
AG1010
Not in Commercial Distribution

  • 08600087686504 ()


  • Chitosan haemostatic agent, professional, non-bioabsorbable
Prescription Use - The Axiostat Gauze is intended for use as a temporary external dressing to control moderate to severe bleeding and manage external abrasions, lacerations. OTC Use - The Axiostat Gauze is indicated for the local management of bleeding wounds such as minor cuts, lacerations, and abrasions.
AXIO BIOSOLUTIONS PRIVATE LIMITED
AG150
Not in Commercial Distribution

  • 08600087686368 ()


  • Chitosan haemostatic agent, professional, non-bioabsorbable
Prescription Use - The Axiostat Gauze is intended for use as a temporary external dressing to control moderate to severe bleeding and manage external abrasions, lacerations. OTC Use - The Axiostat Gauze is indicated for the local management of bleeding wounds such as minor cuts, lacerations, and abrasions.
AXIO BIOSOLUTIONS PRIVATE LIMITED
AG300
Not in Commercial Distribution

  • 08600087686122 ()


  • Chitosan haemostatic agent, professional, non-bioabsorbable
Surearly™ Digital OvulationTest in an in vitro diagnostic medical devices for the rapid determination of Luteinizing Hormone (LH) in urine. The test is for the qualitative detection of LH to predict a woman’s most fertile period. It is intended for non-professional, over-the-counter (OTC) use only.
Sugentech Inc._Osong Branch
SU-DR01-LH
In Commercial Distribution

  • 08809408860863 ()
  • 08809408860245 ()
HLHM020E

  • Luteinizing hormone (LH) IVD, kit, rapid ICT, clinical
Surearly™ Digital OvulationTest in an in vitro diagnostic medical devices for the rapid determination of Luteinizing Hormone (LH) in urine. The test is for the qualitative detection of LH to predict a woman’s most fertile period. It is intended for non-professional, over-the-counter (OTC) use only.
Sugentech Inc._Osong Branch
SU-DR01-LH
In Commercial Distribution

  • 08809408860870 ()
  • 08809408860214 ()
HLHM007E

  • Luteinizing hormone (LH) IVD, kit, rapid ICT, clinical
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.
Red0510
In Commercial Distribution

  • 16971292002465 ()
  • 06971292002468 ()


  • Transcutaneous electrical stimulation electrode, single-use
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