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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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ALT Reagent Set for the quantitative determination of alanine aminotransferase in serum on Hitachi analyzers. For in vitro diagnostic use only. Packaged at 5 x 100ml, 2 x 55ml
POINTE SCIENTIFIC, INC.
HA926-610
In Commercial Distribution

  • 00811727012548 ()
HA926-610

  • Alanine aminotransferase (ALT) IVD, reagent
SuperNova Nitrile Powder-Free, X-Large, Revolutionary stretchy nitrile provides superior comfort and increased tactile sensitivity, Textured fingertips, Packaging contains at least 70% recycled material, More gloves per box reduces packaging
PURELIFE, LLC
1061205
In Commercial Distribution

  • D79010612053 ()
  • D79010612051 ()
  • D79010612050 ()
1061205

  • Nitrile examination/treatment glove, non-powdered, non-antimicrobial
SuperNova Nitrile Powder-Free, Large, Revolutionary stretchy nitrile provides superior comfort and increased tactile sensitivity, Textured fingertips, Packaging contains at least 70% recycled material, More gloves per box reduces packaging
PURELIFE, LLC
1061204
In Commercial Distribution

  • D79010612043 ()
  • D79010612041 ()
  • D79010612040 ()
1061204

  • Nitrile examination/treatment glove, non-powdered, non-antimicrobial
SuperNova Nitrile Powder-Free, Medium, Revolutionary stretchy nitrile provides superior comfort and increased tactile sensitivity, Textured fingertips, Packaging contains at least 70% recycled material, More gloves per box reduces packaging
PURELIFE, LLC
1061203
In Commercial Distribution

  • D79010612033 ()
  • D79010612031 ()
  • D79010612030 ()
1061203

  • Nitrile examination/treatment glove, non-powdered, non-antimicrobial
SuperNova Nitrile Powder-Free, Small, Revolutionary stretchy nitrile provides superior comfort and increased tactile sensitivity, Textured fingertips, Packaging contains at least 70% recycled material, More gloves per box reduces packaging
PURELIFE, LLC
1061202
In Commercial Distribution

  • D79010612023 ()
  • D79010612021 ()
  • D79010612020 ()
1061202

  • Nitrile examination/treatment glove, non-powdered, non-antimicrobial
SuperNova Nitrile Powder-Free, X-Small, Revolutionary stretchy nitrile provides superior comfort and increased tactile sensitivity, Textured fingertips, Packaging contains at least 70% recycled material, More gloves per box reduces packaging
PURELIFE, LLC
1061201
In Commercial Distribution

  • D79010612013 ()
  • D79010612011 ()
  • D79010612010 ()
1061201

  • Nitrile examination/treatment glove, non-powdered, non-antimicrobial
Patient Transportation PTH Kit; Each Kit Includes STAT-BLOC Disposable Premium Antimicrobial Impervious Gurney Sheet with Elastic at the Head and Foot, 40x80 XL Lift Sheet, and STAT-BLOC Disposable Pillowcase.
Bosma Enterprises
10-9030PTH
In Commercial Distribution

  • 10818634020847 ()
  • 00818634020840 ()
10-9030PTH

  • Pillow cover, single-use
  • Patient transfer/turning sheet, single-use
Kit to assist with basic Body Fluids cleanup intended for use at general workplaces, typically accompanying first aid kits for spilled blood or other bodily fluids. Managed First Aid.
REDICARE LLC
Bodily Fluid Cleanup Kit
In Commercial Distribution

  • B70901020740 ()
0102074

  • First aid kit, medicated
Drum is a hearing instrument test box (HIT), with a high ambient noise attenuation level, capable of performing all the tests aimed at hearing aids analysis via air conduction.
INVENTIS SRL
DRUM
In Commercial Distribution

  • 08054187380730 ()
11239

  • Hearing aid tester, electrical
Kit includes: PC-ECG 1200W (UDI: 07290110252076) wireless Stress-Test Kit; Input cable with ten leads AHA type and Clip connectors; Waiste Belt for mounting the wireless transmitter at Patient's hip.
NORAV MEDICAL LTD.
1200W Kit
In Commercial Distribution

  • 07290110255107 ()
1200W2-K-00-U-C10-17

  • Electrocardiography telemetric monitoring system transmitter
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