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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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NexStat Plus 2gm - 00858439001262

The Hemostasis NexStat Plus topical hemostat powder is a sterile, topical wound dressing comprised of plant based polysaccharides. The hemostatic particles quickly dehydrate blood cells, resulting in hemoconcentration of platelets, serum proteins and fibrinogen, leading to clotting that limits and controls bleeding.
HEMOSTASIS, LLC
9430014
In Commercial Distribution

  • 00858439001293 ()
  • 00858439001262 ()

  • Weight: 2 Gram


  • Plant polysaccharide haemostatic agent, non-bioabsorbable, non-antimicrobial

11" Stainless Steel Guidewire - 00858406007587

No Description
SURGENTEC, LLC
FC-G-16
In Commercial Distribution

  • 00858406007587 ()


  • Spinal guidewire

9" Stainless Steel Guidewire - 00858406007570

No Description
SURGENTEC, LLC
FC-G-16S
In Commercial Distribution

  • 00858406007570 ()


  • Spinal guidewire

4.5mm Drill Bit - 00858406007495

No Description
SURGENTEC, LLC
FC-D-45
In Commercial Distribution

  • 00858406007495 ()


  • Fluted surgical drill bit, reusable

HotHands Therapy - 00667560800138

Warming Earplugs
KOBAYASHI CONSUMER PRODUCTS, LLC
667560800138
In Commercial Distribution

  • 10667560800135 ()
  • 00667560800138 ()
  • 10667560800203 ()


  • Earplugs, reusable

HemCon® Dental Dressing PRO, 1in x 3in - 00870053001114

The HemCon Dental Dressing PRO is a chitosan-based oral wound dressing intended as a physical barrier for temporary protection of oral mucosal tissue and to provide pain relief.
TRICOL BIOMEDICAL, INC.
1
In Commercial Distribution

  • 20870053001118 ()
  • 00870053001114 ()
  • 50870053001119 ()
1052

  • General oral wound dressing, animal-derived

HemCon® Dental Dressing PRO, 10mm x 12mm - 00870053001039

The HemCon Dental Dressing PRO is a chitosan-based oral wound dressing intended as a physical barrier for temporary protection of oral mucosal tissue and to provide pain relief.
TRICOL BIOMEDICAL, INC.
1
In Commercial Distribution

  • 20870053001033 ()
  • 00870053001039 ()
  • 50870053001034 ()
1050

  • General oral wound dressing, animal-derived

Acuicyn Eyelid & Eyelash Hygiene - 00868489000283

No Description
Sonoma Pharmaceuticals, Inc.
85024
In Commercial Distribution

  • 20868489000287 ()
  • 00868489000283 ()

  • Total Volume: 80 Milliliter
85024

  • Eyelid solution

Acuicyn Eyelid & Eyelash Hygiene - 00868489000276

No Description
Sonoma Pharmaceuticals, Inc.
85023
In Commercial Distribution

  • 20868489000270 ()
  • 00868489000276 ()

  • Total Volume: 40 Milliliter
85023

  • Eyelid solution

GrindRelief PRO - 00866618000050

Thermoplastic mouth guard - Case of 3
Grind Guard Technologies, L.L.C.
203
In Commercial Distribution

  • 10866618000033 ()
  • 00866618000050 ()
203

  • Mouthguard, reusable
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