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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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PriMatrix is an acellular dermal tissue matrix. The device is supplied sterile and is provided in sheet form in a variety of sizes to be trimmed by the surgeon to meet the individual patient's needs.
TEI BIOSCIENCES INC.
6495-9-104
Not in Commercial Distribution

  • 10381780113652 ()

  • 4 x 4 x (0.20 - 1.04) cm x cm x mm
6495-9-104

  • Animal-derived wound matrix dressing
PriMatrix is an acellular dermal tissue matrix. The device is supplied sterile and is provided in sheet form in a variety of sizes to be trimmed by the surgeon to meet the individual patient's needs.
TEI BIOSCIENCES INC.
607-005-220
Not in Commercial Distribution

  • 10381780113416 ()

  • 2 x 2 x (0.20 - 1.04) cm x cm x mm
607-005-220

  • Animal-derived wound matrix dressing
Hemostatic Z-Fold Gauze - Non-woven gauze coated with Celox hemostatic granules with Chito-R technology. Dressing is indicated for temporary external use to control bleeding of lacerations, minor cuts, and abrasions. For use by a trained emergency responder.
MEDTRADE PRODUCTS LIMITED
FG08839241
In Commercial Distribution

  • 15060206631318 ()
  • 75060206631310 ()

  • 3in x 2ft Z-fold
  • Length: 2 Feet
  • Width: 3 Inch
FG08839241

  • Chitosan haemostatic agent, professional, non-bioabsorbable
HYBENX Advanced Dental Debridement is a topical liquid or gel intended for use as an adjunctive decontamination rinse of tooth surfaces during the performance of certain dental procedures to help remove the smear layer and tooth debris.
Epien Medical, Inc.
109-0004
In Commercial Distribution

  • 00860004740322 ()

  • Total Volume: 1.5 Milliliter
109-0004

  • Dental mouthwash
BIAKOS™ Antimicrobial Skin & Wound Cleanser helps in the mechanical removal of debris and foreign material from the skin, wound or application site. BIAKOS™ is a broad-spectrum skin and wound cleanser that is safe to use.
Sanara Medtech Inc.
AWC0810
In Commercial Distribution

  • 20860000939557 ()
  • 00860000939553 ()


  • Antimicrobial wound irrigation solution
BIAKOS™ Antimicrobial Skin & Wound Cleanser helps in the mechanical removal of debris and foreign material from the skin, wound or application site. BIAKOS™ is a broad-spectrum skin and wound cleanser that is safe to use.
Sanara Medtech Inc.
AWC0401
In Commercial Distribution

  • 00860000939539 ()
  • 10860000939536 ()


  • Antimicrobial wound irrigation solution
Picis Perioperative and Critical Care: An EMR system used in high acuity areas of the hospital (OR, ICU, Preop, PACU). A patient record is populated with information such as healthcare professionals, medical devices, and HIS/lab systems.
Picis Clinical Solutions, Inc.
10
In Commercial Distribution

  • 00851831007078 ()


  • Patient health record information system application software
PuraPly™ Wound Matrix consists of a single-layer fenestrated sheet of collagen intended for the management of wounds. PuraPly™ Wound Matrix is supplied dry in sheet form. The device is packaged in sterile, sealed single pouches.
ORGANOGENESIS INC.
515-024
In Commercial Distribution

  • 00618474000152 ()
  • 00618474000145 ()

  • Width: 3.05 Centimeter
  • Length: 2.05 Centimeter


  • Animal-derived wound matrix dressing
PuraPly™ Wound Matrix consists of a single-layer fenestrated sheet of collagen intended for the management of wounds. PuraPly™ Wound Matrix is supplied dry in sheet form. The device is packaged in sterile, sealed single pouches.
ORGANOGENESIS INC.
515-012
In Commercial Distribution


  • Width: 9 Centimeter
  • Length: 6 Centimeter


  • Animal-derived wound matrix dressing
PuraPly™ Wound Matrix consists of a single-layer fenestrated sheet of collagen intended for the management of wounds. PuraPly™ Wound Matrix is supplied dry in sheet form. The device is packaged in sterile, sealed single pouches.
ORGANOGENESIS INC.
515-006
In Commercial Distribution

  • 00618474000060 ()

  • Width: 5 Centimeter
  • Length: 5 Centimeter


  • Animal-derived wound matrix dressing
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