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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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For the debridement and irrigation of root canals during and after instrumentation. 3ml kit.
Vista Dental
502355
In Commercial Distribution

  • 10818207020410 ()
  • 00818207020413 ()


  • Antimicrobial wound irrigation solution
Remote Port Tissue Expander Accessories, For Use with SSP Remote Injection Port Tissue Expanders
SPECIALTY SURGICAL PRODUCTS INC
RPA01
Not in Commercial Distribution

  • M746RPA010 ()
RPA01

  • Skin-port tissue expander
For Administration of Blood and Blood Components During a Therapeutic Plasma Exchange (TPE) or Red Blood Cell Exchange (RBCX) Therapeutic Apheresis Procedure. For use with the AMICUS separator. Sterile Fluid Path.
Fresenius Kabi AG
X6C2170
In Commercial Distribution

  • 04086000100168 ()
  • 04052682031717 ()
  • 14052682031714 ()
X6C2170

  • Blood transfusion set, non-exchange
Adhesive Strip 3in x 1in (Box of 150). Bandage is not directly marked with UDI information. As well, the pouch size for the bandage does not have enough space for labeling.
ARGENTUM MEDICAL, LLC
AS-6001
In Commercial Distribution

  • 10857278000273 ()
  • 00857278000276 ()


  • Adhesive bandage
Adhesive Strips 3in x 1in (Box of 24). Bandage is not directly marked with UDI information. As well, the pouch size for the bandage does not have enough space for labeling.
ARGENTUM MEDICAL, LLC
AS-6003
In Commercial Distribution

  • 10857278000198 ()
  • 00857278000191 ()


  • Adhesive bandage
Hemostatic Gauze. The device is indicated for: Temporary external treatment to control moderate to severe bleeding Temporary topical dressing for bleeding control associated with minor wounds including control of minor external bleeding and exudate from sutures and/or surgical procedures. Hemostatic gauze is for temporary external use only
MEDTRADE PRODUCTS LIMITED
FG07734331
In Commercial Distribution

  • 75060206630597 ()
  • 35060206630599 ()
  • 15060206630595 ()

  • Width: 17 Millimeter
  • Length: 120 Millimeter
  • Supplied folded size 17mm by 60mm
FG07734331

  • Chitosan haemostatic agent, professional, non-bioabsorbable
HELICOLL is a biological, sterile, reconstituted bovine Type-I Collagen Sheet of 1.6x1.6 inches intended for the treatment of Wounds, Burns, and Ulcers. HELICOLL collagen sheet is free of contaminants and US Patented for further unique physiological modification. HELICOLL collagen is biodegradable and highly bioactive matrix for capillary growth and tissue regeneration.
ENCOLL CORP.
HC1.6x1.6
In Commercial Distribution

  • 00860000744485 ()
  • 10860000744482 ()
HC1.6x1.6

  • Collagen wound matrix dressing
HELICOLL is a biological, sterile, reconstituted bovine Type-I Collagen Sheet of 1.2x1.6 inches intended for the treatment of Wounds, Burns, and Ulcers. HELICOLL collagen sheet is free of contaminants and US Patented for further unique physiological modification. HELICOLL collagen is biodegradable and highly bioactive matrix for capillary growth and tissue regeneration.
ENCOLL CORP.
HC1.2x1.6
In Commercial Distribution

  • 00860000744478 ()
  • 10860000744475 ()
HC1.2x1.6

  • Collagen wound matrix dressing
HELICOLL is a biological, sterile, reconstituted bovine Type-I Collagen Sheet of 0.8x1.6 inches intended for the treatment of Wounds, Burns, and Ulcers. HELICOLL collagen sheet is free of contaminants and US Patented for further unique physiological modification. HELICOLL collagen is biodegradable and highly bioactive matrix for capillary growth and tissue regeneration.
ENCOLL CORP.
HC0.8x1.6
In Commercial Distribution

  • 00860000744461 ()
  • 10860000744468 ()
HC0.8x1.6

  • Collagen wound matrix dressing
HELICOLL is a biological, sterile, reconstituted bovine Type-I Collagen Sheet of 8x8 inches intended for the treatment of Wounds, Burns, and Ulcers. HELICOLL collagen sheet is free of contaminants and US Patented for further unique physiological modification. HELICOLL collagen is biodegradable and highly bioactive matrix for capillary growth and tissue regeneration.
ENCOLL CORP.
HC8x8
In Commercial Distribution

  • 00860000744430 ()
  • 10860000744437 ()
HC8x8

  • Collagen wound matrix dressing
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