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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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Kerecis® Omega3 BURN - 05694310960410

Acellular fish skin for topical and surgical wounds. INTENDED USE Kerecis® Burn is indicated for the management of wounds including: - Partial and full-thickness wounds, - Trauma wounds (abrasions, lacerations, second-degree burns, skin tears). Double Pouched https://www.kerecis.com/wp-content/uploads/2020/10/A5-KM-19-0146-IFU-Kerecis-Burn-US.pdf
KERECIS hf.
10x25 Solid Burn
In Commercial Distribution

  • 05694310960410 ()

  • Length: 10 Centimeter
  • Width: 25 Centimeter
50202S22D0D

  • Animal-derived wound matrix dressing

Kerecis® Omega3 BURN - 05694310960564

Acellular fish skin for topical and surgical wounds. INTENDED USE Kerecis® Burn is indicated for the management of wounds including: - Partial and full-thickness wounds, - Trauma wounds (abrasions, lacerations, second-degree burns, skin tears). Trapezoid Double Pouched https://www.kerecis.com/wp-content/uploads/2020/10/A5-KM-19-0146-IFU-Kerecis-Burn-US.pdf
KERECIS hf.
300cm2 Meshed Burn
In Commercial Distribution

  • 05694310960571 ()
  • 05694310960564 ()

  • Length: 7 Centimeter
  • Width: 7 Centimeter
50202S23D0D

  • Animal-derived wound matrix dressing

Kerecis® Omega3 BURN - 05694310960038

Acellular fish skin for topical and surgical wounds. INTENDED USE Kerecis® Burn is indicated for the management of wounds including: - Partial and full-thickness wounds, - Trauma wounds (abrasions, lacerations, second-degree burns, skin tears). Meshed Double Pouched https://www.kerecis.com/wp-content/uploads/2020/10/A5-KM-19-0146-IFU-Kerecis-Burn-US.pdf
KERECIS hf.
7x20 Meshed Burn
In Commercial Distribution

  • 05694310960045 ()
  • 05694310960038 ()

  • Length: 7 Centimeter
  • Width: 20 Centimeter
50202M14B0D

  • Animal-derived wound matrix dressing

Kerecis® Omega3 BURN - 05694310960014

Acellular fish skin for topical and surgical wounds. INTENDED USE Kerecis® Burn is indicated for the management of wounds including: - Partial and full-thickness wounds, - Trauma wounds (abrasions, lacerations, second-degree burns, skin tears). Meshed Double Pouched https://www.kerecis.com/wp-content/uploads/2020/10/A5-KM-19-0146-IFU-Kerecis-Burn-US.pdf
KERECIS hf.
7x10 Meshed Burn
In Commercial Distribution

  • 05694310960021 ()
  • 05694310960014 ()

  • Length: 7 Centimeter
  • Width: 10 Centimeter
50202M13B0D

  • Animal-derived wound matrix dressing

Caphosol - 05060146291576

Caphosol is a preparation comprising two separately packaged aqueous solutions, a phosphate solution (Caphosol A) and a calcium solution (Caphosol B) which when both ampule solutions are combined in equal volumes form a solution supersaturated with respect to both calcium and phosphate ions.
EUSA PHARMA (UK) LIMITED
64 x 15 mL ampules aqueous solution
Not in Commercial Distribution

  • 05060146291576 ()


  • Artificial saliva

ACTEON - 03760243000959

HEMOSTASYL is a paste to be used as a haemostatic dressing with a mechanical action. Kit containing: 2 x 2g syringes of HEMOSTASYL Paste (about 30 uses) and 40 HEMOSTASYL angled application cannulas. Syringe for multiple uses. Application cannulas for single use.
ACTEON MANUFACTURING
Hemostasyl Kit
Not in Commercial Distribution

  • 03760243000959 ()
246200

  • Non-organic haemostatic agent

LIFECODES LifeScreen XP - 10888234500841

LIFECODES LifeScreen XP is a manual, qualitative bead-based immunoassay used to detect IgG antibodies to HLA Class I and Class II molecules in patients sensitized to HLA by transfusion, pregnancy, or transplantation to aid donor and recipient match in transfusion or transplantation.
IMMUCOR GTI DIAGNOSTICS, INC.
628220
In Commercial Distribution

  • 10888234500841 ()
628220

  • HLA class I & II antigen tissue typing IVD, kit, multiplex

Saljet - 10188151000005

Saljet 40 is a single use disposable polymer vial with a twist off top containing 30ml of sterile normal saline 0.9% w/v. It contains no preservatives, surfactants or buffering. The vials are packed into an outer shelf carton. Forty vials per carton.
WINCHESTER LABORATORIES LLLP
Saljet 40
In Commercial Distribution

  • 10188151000005 ()
  • 00188151000008 ()
  • 30188151000009 ()


  • Wound irrigation sterile saline

Panthera Occlusal Appliance - Single - 07540204000077

The Panthera Occlusal Appliance is indicated for protection of teeth and restorations from the forces and damage of parafunctions like bruxism, prevention of noise associated with bruxism, and for alleviation of temporomandibular joint, muscle and tension headache pains associated with temporomandibular disorders.
Panthera Dentaire Inc
1
In Commercial Distribution

  • 07540204000077 ()


  • Removable dental occlusal splint, custom-made

Saljet - 20188151000002

Saljet 6 is a single use disposable polymer vial with a twist off top containing 30ml of sterile normal saline 0.9% w/v. It contains no preservatives, surfactants or buffering. The vials are packed into an outer shelf carton. six vials per carton.
WINCHESTER LABORATORIES LLLP
Saljet 6
In Commercial Distribution

  • 20188151000002 ()
  • 00188151000008 ()
  • 40188151000006 ()


  • Wound irrigation sterile saline
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