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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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Azur Nitrile Powder-Free, Large, Ultra-soft nitrile, Super stretchy for superior comfort, Packaging contains at least 80% recycled material, More gloves per box reduces packaging
PURELIFE, LLC
1061704
In Commercial Distribution

  • D79010617043 ()
  • D79010617041 ()
  • D79010617040 ()
1061704

  • Nitrile examination/treatment glove, non-powdered, non-antimicrobial
Azur Nitrile Powder-Free, Medium, Ultra-soft nitrile, Super stretchy for superior comfort, Packaging contains at least 80% recycled material, More gloves per box reduces packaging
PURELIFE, LLC
1061703
In Commercial Distribution

  • D79010617033 ()
  • D79010617031 ()
  • D79010617030 ()
1061703

  • Nitrile examination/treatment glove, non-powdered, non-antimicrobial
Azur Nitrile Powder-Free, Small, Ultra-soft nitrile, Super stretchy for superior comfort, Packaging contains at least 80% recycled material, More gloves per box reduces packaging
PURELIFE, LLC
1061702
In Commercial Distribution

  • D79010617023 ()
  • D79010617021 ()
  • D79010617020 ()
1061702

  • Nitrile examination/treatment glove, non-powdered, non-antimicrobial
Azur Nitrile Powder-Free, X-Small, Ultra-soft nitrile, Super stretchy for superior comfort, Packaging contains at least 80% recycled material, More gloves per box reduces packaging
PURELIFE, LLC
1061701
In Commercial Distribution

  • D79010617013 ()
  • D79010617011 ()
  • D79010617010 ()
1061701

  • Nitrile examination/treatment glove, non-powdered, non-antimicrobial
PCRopsis™ Reagent RVD-RT (1000 mL) mediates extraction-free PCR from saliva, urine, and swab specimens transported in compatible universal transport medium at room temperature.
ENTOPSIS, LLC
Reagent RVD-RT
Not in Commercial Distribution

  • B5507837810000 ()
783781000

  • Nucleic acid extraction/isolation kit IVD
PCRopsis™ Reagent RVD-RT (100 mL) mediates extraction-free PCR from saliva, urine, and swab specimens transported in compatible universal transport medium at room temperature.
ENTOPSIS, LLC
Reagent RVD-RT
Not in Commercial Distribution

  • B550783781000 ()
78378100

  • Nucleic acid extraction/isolation kit IVD
PCRopsis™ Reagent RVD-RT (25 mL) mediates extraction-free PCR from saliva, urine, and swab specimens transported in compatible universal transport medium at room temperature.
ENTOPSIS, LLC
Reagent RVD-RT
Not in Commercial Distribution

  • B550783780250 ()
78378025

  • Nucleic acid extraction/isolation kit IVD
Blumenthal Tapered Hydrodelineation Cannula, 25 Gauge, Angled 4mm from bend to tip at 45°, tip is tapered to provide easy insertion, 22mm tip length
Diamatrix
C379
In Commercial Distribution

  • 00813059015419 ()


  • Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, reusable
Melles DSAEK PLK Scraper, Style 2, 90° Angled tip, Angled 11mm from bend to tip at 90°, Diamond knurled handle, 125mm total length, Stainless.
Diamatrix
H305-2S
In Commercial Distribution

  • 00813059015303 ()


  • Ocular hook/spatula/manipulator, reusable
Binkhorst Irrigating Cannula 22ga Left with 2.4mm (1mm ID) J-Shaped hook tip, Angled 30 Degree at 13mm from bend to tip, 35mm Overall Length
Crestpoint Management Limited
CA355
In Commercial Distribution

  • G412CA3550 ()


  • Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, reusable
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