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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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Acellular fish skin for topical and surgical wounds. INTENDED USE Kerecis® Wound is indicated for the management of wounds including: •Partial and full-thickness wounds •Pressure ulcers •Venous ulcers •Chronic vascular ulcers •Diabetic ulcers •Trauma wounds (abrasions, lacerations, second-degree burns, skin tears) •Surgical wounds (donor sites/grafts, post-Mohs surgery, post-laser surgery, podiatric, wound dehiscence) •Draining Wounds https://www.kerecis.com/ifus/ifu-kerecis-omega3-marigen/
KERECIS hf.
12 mm Solid Circular Wound
Not in Commercial Distribution

  • 05694310960120 ()
  • 05694310960113 ()

  • Circumference: 12 Millimeter
50200S12B0D

  • Collagen wound matrix dressing
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.
MX1010
In Commercial Distribution

  • 00860012016617 ()


  • Chitosan haemostatic agent, professional, non-bioabsorbable
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.
MX0510
In Commercial Distribution

  • 00860012016600 ()


  • Chitosan haemostatic agent, professional, non-bioabsorbable
The ARK Methotrexate Assay (non c-Pack format) is a homogeneous enzyme immunoassay intended for the quantitative determination of methotrexate in human serum or plasma on automated clinical chemistry analyzers.
ARK DIAGNOSTICS INC
5026-0001-01
In Commercial Distribution

  • 00858724003216 ()
5026-0001-01

  • Methotrexate therapeutic drug monitoring IVD, kit, enzyme immunoassay (EIA)
Capture-R Ready-Screen (3) is intended for use in the detection of unexpected IgG antibodies to red blood cells by manual, semi-automated or automated solid phase red blood cell adherence methods.
IMMUCOR, INC.
0066901
In Commercial Distribution

  • 10888234001539 ()
0066901

  • Solid-phase red blood cell adherence antibody/antigen IVD
The COM.TEC Blood Cell Separator is a blood cell separator which utilizes centrifugal force as the basis for operation. The fields of application are as follows: - Plasma exchange - Plasma treatment
Fresenius Kabi AG
9008031
In Commercial Distribution

  • 04086000860154 ()
9008031

  • Apheresis system
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

  • Collagen 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

  • Collagen 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

  • Collagen 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

  • Collagen wound matrix dressing
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