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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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TE, CURVE SHAPE, ENHANCED SURFACE, REMOTE PORT, 10X30CM, 1000CC FILL, 4.3CM PROJECTION
PMT CORPORATION
3614ES-552
In Commercial Distribution

  • 00650551000297 ()


  • Skin-port tissue expander
TE, RECTANGLE SHAPE, SMOOTH SURFACE, 2-STAGE, INTERNAL PORT, 12X16CM, 1476CC FILL, 10CM PROJECTION
PMT CORPORATION
3610-622-2I
In Commercial Distribution

  • 00650551000235 ()


  • Skin-port tissue expander
A colourless, odourless gel in a plastic tube with tamper evident seal and screw-top.
Lifestream Pharma
Oral Moisturizing Gel 15ml
In Commercial Distribution

  • 05425005127517 ()
  • 05425005127524 ()


  • Oropharyngeal mucosa protection material
Fish-skin graft for wound management. Kerecis® MariGen™ 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) and draining wounds. https://www.kerecis.com/ifus/ifu-kerecis-marigen/
KERECIS hf.
Micro 38 sq cm
In Commercial Distribution

  • 05694310961660 ()
  • 05694310961653 ()

  • Area/Surface Area: 38 Square centimeter
50200P04D0D

  • Animal-derived wound matrix dressing
Fish-skin graft for wound management. Kerecis® MariGen™ 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) and draining wounds. IFU: https://www.kerecis.com/ifus/ifu-kerecis-marigen/
KERECIS hf.
Micro 19 sq cm
In Commercial Distribution

  • 05694310961622 ()
  • 05694310961615 ()

  • Area/Surface Area: 19 Square centimeter
50200P02D0D

  • Animal-derived wound matrix dressing
Fish-skin graft for wound management. Kerecis® MariGen™ 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) and draining wounds. IFU: https://www.kerecis.com/ifus/ifu-kerecis-marigen/
KERECIS hf.
Micro 8 sq cm
In Commercial Distribution

  • 05694310961608 ()
  • 05694310961592 ()

  • Area/Surface Area: 8 Square centimeter
50200P01B0D

  • Animal-derived wound matrix dressing
Fish-skin graft for wound management. Kerecis® Marigen™ 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) and draining wounds. IFU: https://www.kerecis.com/ifus/ifu-kerecis-marigen/
KERECIS hf.
Micro 4 sq cm
In Commercial Distribution

  • 05694310961578 ()
  • 05694310961585 ()

  • Area/Surface Area: 4 Square centimeter
50200P00B0D

  • Animal-derived wound matrix dressing
Fish-Skin Graft for Surgical Use. Kerecis® SurgiClose® is indicated for the management of wounds including: Partial and full thickness wounds, pressure ulcers, chronic vascular ulcers, diabetic ulcers, trauma wounds (abrasions, lacerations, second-degree burns, skin tears), surgical wounds (donor site/grafts, post-Mohs surgery, post-laser surgery, podiatric, wound dehiscence) and draining wounds. IFU: https://www.kerecis.com/ifus/ifu-kerecis-surgiclose/
KERECIS hf.
Micro 38 sq cm
In Commercial Distribution

  • 05694310961554 ()
  • 05694310961561 ()

  • Area/Surface Area: 38 Square centimeter
50205P04D0D

  • Animal-derived wound matrix dressing
Fish-Skin Graft for Surgical Use. Kerecis® SurgiClose® is indicated for the management of wounds including: Partial and full thickness wounds, pressure ulcers, chronic vascular ulcers, diabetic ulcers, trauma wounds (abrasions, lacerations, second-degree burns, skin tears), surgical wounds (donor site/grafts, post-Mohs surgery, post-laser surgery, podiatric, wound dehiscence) and draining wounds. IFU: https://www.kerecis.com/ifus/ifu-kerecis-surgiclose/
KERECIS hf.
Micro 19 sq cm
In Commercial Distribution

  • 05694310961547 ()
  • 05694310961530 ()

  • Area/Surface Area: 19 Square centimeter
50205P02D0D

  • Animal-derived wound matrix dressing
Fish-Skin Graft for Surgical Use. Kerecis® SurgiClose® is indicated for the management of wounds including: Partial and full thickness wounds, pressure ulcers, chronic vascular ulcers, diabetic ulcers, trauma wounds (abrasions, lacerations, second-degree burns, skin tears), surgical wounds (donor site/grafts, post-Mohs surgery, post-laser surgery, podiatric, wound dehiscence) and draining wounds. IFU: https://www.kerecis.com/ifus/ifu-kerecis-surgiclose/
KERECIS hf.
Micro 19 sq cm
Not in Commercial Distribution

  • 05694310961509 ()
  • 05694310961493 ()

  • Area/Surface Area: 19 Square centimeter
50205P02D0D

  • Animal-derived wound matrix dressing
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