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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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The OneStop™ Dressing is a wound dressing manufactured from chitosan. When applied directly to the wound, the OneStop™ dressing controls bleeding. The OneStop™ dressing offers an antibacterial barrier against a wide range of gram positive and gram negative organisms, including antibiotic resistant Staphylococcus aureus (MRSA), Enterococcus faecalis (VRE) and Acinetobacter baumannii. Only single strains of most species mentioned have been studied.
TRICOL BIOMEDICAL, INC.
1
In Commercial Distribution

  • 20870053000401 ()
  • 00870053000407 ()
  • 50870053000402 ()
1103

  • Chitosan haemostatic agent, professional, non-bioabsorbable
Neurosurgical Long Extension Shroud: The shrouds are intended to direct the saline irrigation fluid to the site of operation. Shroud Black heat resistant shrouds that are interconnected by snap-in push fittings with the exception of the laparoscopic handpiece which has a screw thread joint. The shrouds cover one or two titanium alloy parts. All handpieces contain a tip. Angled handpieces also include an angled extension.
INTEGRA LIFESCIENCES (IRELAND) LIMITED
1523045
Not in Commercial Distribution

  • 10381780040712 ()
  • 00381780040715 ()

  • 24kHz Ultrasonic Frequency


  • Soft-tissue ultrasonic surgical system handpiece, reusable
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
FDSD0810
In Commercial Distribution

  • 10860008106572 ()
FDSD0810

  • Animal-derived wound matrix dressing
INTEGRA Bilayer Matrix Wound Dressing is an advanced woundcare device comprised of a porous matrix of cross-linked bovine tendon collagen and glycosaminoglycan and a semi-permeable polysiloxane (silicone) layer. The semi-permeable silicone membrane controls water vapor loss, provides a flexible adherent covering for the wound surface and adds increased tear strength to the device. The collagen-glycosaminoglycan biodegradable matrix provides a scaffold for cellular invasion and capillary growth.
Integra Lifesciences Corporation
BMW810
In Commercial Distribution

  • M269BMW8101 ()
  • 10381780032274 ()
  • 00381780032277 ()

  • Width: 8 Inch
  • Length: 10 Inch
  • Width: 20 Centimeter
  • Length: 25 Centimeter
BMW810

  • Animal-derived wound matrix dressing
INTEGRA Bilayer Matrix Wound Dressing is an advanced woundcare device comprised of a porous matrix of cross-linked bovine tendon collagen and glycosaminoglycan and a semi-permeable polysiloxane (silicone) layer. The semi-permeable silicone membrane controls water vapor loss, provides a flexible adherent covering for the wound surface and adds increased tear strength to the device. The collagen-glycosaminoglycan biodegradable matrix provides a scaffold for cellular invasion and capillary growth.
Integra Lifesciences Corporation
BMW410
In Commercial Distribution

  • M269BMW4101 ()
  • 10381780032267 ()
  • 00381780032260 ()

  • Length: 10 Inch
  • Length: 25 Centimeter
  • Width: 10 Centimeter
  • Width: 4 Inch
BMW410

  • Animal-derived wound matrix dressing
INTEGRA Bilayer Matrix Wound Dressing is an advanced woundcare device comprised of a porous matrix of cross-linked bovine tendon collagen and glycosaminoglycan and a semi-permeable polysiloxane (silicone) layer. The semi-permeable silicone membrane controls water vapor loss, provides a flexible adherent covering for the wound surface and adds increased tear strength to the device. The collagen-glycosaminoglycan biodegradable matrix provides a scaffold for cellular invasion and capillary growth.
Integra Lifesciences Corporation
BMW405
In Commercial Distribution

  • M269BMW4051 ()
  • 10381780032250 ()
  • 00381780032253 ()

  • Width: 4 Inch
  • Width: 10 Centimeter
  • Length: 12.5 Centimeter
  • Length: 5 Inch
BMW405

  • Animal-derived wound matrix dressing
INTEGRA Bilayer Matrix Wound Dressing is an advanced woundcare device comprised of a porous matrix of cross-linked bovine tendon collagen and glycosaminoglycan and a semi-permeable polysiloxane (silicone) layer. The semi-permeable silicone membrane controls water vapor loss, provides a flexible adherent covering for the wound surface and adds increased tear strength to the device. The collagen-glycosaminoglycan biodegradable matrix provides a scaffold for cellular invasion and capillary growth.
Integra Lifesciences Corporation
BMW202
In Commercial Distribution

  • 10381780032243 ()
  • 00381780032246 ()
  • M269BMW2021 ()

  • Width: 5 Centimeter
  • Length: 2 Inch
  • Width: 2 Inch
  • Length: 5 Centimeter
BMW202

  • Animal-derived wound matrix dressing
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
FDSD0103
In Commercial Distribution

  • 00860008106582 ()
FDSD0103

  • Animal-derived wound matrix dressing
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
FDSD0008
In Commercial Distribution

  • 00860008106575 ()
FDSD0008

  • Animal-derived wound matrix dressing
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
FDSD0010
In Commercial Distribution

  • 00860008106568 ()
FDSD0010

  • Animal-derived wound matrix dressing
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