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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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NeoMatriX Wound Matrix is a sterile, wound dressing fabricated from the dermal extracellular matrix of axolotl. NeoMatriX is provided as sheets of various sizes for placement on wound beds to help manage the wound environment. This device is terminally sterilized using gamma irradiation. NeoMatriX wound matrix provides an adherent covering that protects the wound from the environment. The device is intended for one time use.
NEXTGEN BIOLOGICS INC
FDSD0307
Not in Commercial Distribution

  • 00860008106506 ()
FDSD0307

  • Collagen wound matrix dressing
TendoNova Disposable Unit 60mm Kit-Single
Tendonova Corporation
DU1F60L-K
In Commercial Distribution

  • 00860009899865 ()

  • Length: 60 Millimeter


  • Skin topical coupling gel
  • Soft-tissue ultrasonic surgical system handpiece tip, single-use
  • Skin-cover adhesive strip, non-antimicrobial
  • Patient surgical drape, single-use
  • Orthopaedic implant aiming arm
TendoNova Disposable Unit 80mm Kit-Single
Tendonova Corporation
DU1F80L-K
In Commercial Distribution

  • 00860009899858 ()

  • Length: 80 Millimeter


  • Soft-tissue ultrasonic surgical system handpiece tip, single-use
  • Spiral blade
  • Skin topical coupling gel
  • Skin-cover adhesive strip, non-antimicrobial
  • Patient surgical drape, single-use
SURGI-STOP, HEMOSTATIC WOUND DRESSING, 40 PER BOX
Terlain Enterprises, Inc.
SDWD-01
In Commercial Distribution

  • 10860011605703 ()
  • 00860011605706 ()


  • General oral wound dressing, non-animal-derived
CHG 100 TendoNova Ocelot Nano Charger
Tendonova Corporation
CHG-100
In Commercial Distribution

  • 00860008843524 ()


  • Soft-tissue ultrasonic surgical system handpiece, reusable
RDU 1000 TendoNova Ocelot Nano Reusable Drive Unit
Tendonova Corporation
RDU-1000
In Commercial Distribution

  • 00860008843517 ()


  • Soft-tissue ultrasonic surgical system handpiece, reusable
TendoNova Ocelot DU1F60L Disposable Unit- 60mm
Tendonova Corporation
DU1F60L
In Commercial Distribution

  • 10860008843507 ()
  • 00860008843500 ()

  • Length: 60 Millimeter


  • Soft-tissue ultrasonic surgical system handpiece tip, single-use
The MaxioCel Chitosan Wound Dressing is a soft, sterile, single-use absorbent gelling wound dressing used for absorption of wound exudate. The Maxiocel Chitosan Wound Dressing helps in maintaining a moist, optimal wound healing environment, helps in autolytic debridement, and is easy to remove. The Maxiocel Chitosan Wound.Dressing can be kept on the wound site for up to 7 days.
Advamedica Inc.
MX2530
In Commercial Distribution

  • 00860008768698 ()


  • Chitosan haemostatic agent, professional, non-bioabsorbable
Axiostat Patch is intended for local management of bleeding wounds and to provide a barrier to bacterial penetration of the dressing for patients and for the rapid control of moderate to severe bleeding. The dressing is indicated for the following wounds: lacerations, abrasions, surgical debridement sites, skin surface puncture sites, vascular procedure sites and sites involving percutaneous catheters, tubes and pins.
Advamedica Inc.
L88
In Commercial Distribution

  • 00860008768681 ()


  • Chitosan haemostatic agent, professional, non-bioabsorbable
Prescription Use - The Axiostat Gauze is intended for use as a temporary external dressing to control moderate to severe bleeding and manage external abrasions, lacerations. OTC Use - The Axiostat Gauze is indicated for the local management of bleeding wounds such as minor cuts, lacerations, and abrasions.
Advamedica Inc.
AG4010
In Commercial Distribution

  • 00860008768674 ()


  • Chitosan haemostatic agent, professional, non-bioabsorbable
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