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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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● 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
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
The Sure + is intended to provide electrical stimulation and neuromuscular re-education for the purpose of rehabilitation of weak pelvic floor muscles for the treatment of stress, urge, and mixed urinary incontinence in women and to maintain urinary continence in women. The Sure + is intended for OTC use.
TENSCARE LIMITED
Sure+
In Commercial Distribution

  • 05033435134458 ()
K-SURE+USA

  • Perineal orifice incontinence-control electrical stimulation system
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.
Advamedica Inc.
AG4010
In Commercial Distribution

  • 00860008768674 ()


  • 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.
Advamedica Inc.
AG1010
In Commercial Distribution

  • 00860008768650 ()


  • 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.
Advamedica Inc.
AG150
In Commercial Distribution

  • 00860008768636 ()


  • 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.
Advamedica Inc.
AG300
In Commercial Distribution

  • 00860008768612 ()


  • Chitosan haemostatic agent, professional, non-bioabsorbable
The David Ovulation Test (Urine) is a self-testing rapid chromatographic immunoassay for the qualitative detection of human luteinizing hormone (LH) in urine to predict the time of ovulation. This test strip is used to obtain a visual result. It is intended for non-professional, over-the counter (OTC) use.
Equinox Biotech Co., Ltd.
80074
Not in Commercial Distribution

  • 06938444980074 ()
  • 06938444980098 ()
RH-LH-B

  • Luteinizing hormone (LH) IVD, kit, rapid ICT, clinical
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