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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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KERECIS hf.
Expanse 4x4 cm
In Commercial Distribution

  • 05694310964517 ()
  • 05694310964500 ()

  • Width: 4 Centimeter
  • Length: 3 Centimeter
50200N44B0D

  • Collagen 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.
Expanse 3x3 cm
In Commercial Distribution

  • 05694310964494 ()
  • 05694310964487 ()

  • Length: 3 Centimeter
  • Width: 3 Centimeter
50200N43B0D

  • Collagen 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.
Expanse 2x2 cm
In Commercial Distribution

  • 05694310964470 ()
  • 05694310964463 ()

  • Length: 2 Centimeter
  • Width: 2 Centimeter
50200N42B0D

  • Collagen wound matrix dressing
Bilayer wound management medical device product made from fish skin and silicone. Kerecis® Shield™ Spiral 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, partial-thickness 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-shield/
KERECIS hf.
Diameter: 30mm
In Commercial Distribution

  • 05694310964371 ()
  • 05694310964364 ()

  • Outer Diameter: 30 Millimeter
50215K52B0D

  • Collagen wound matrix dressing
Bilayer wound management medical device product made from fish skin and silicone. Kerecis® Shield™ Standard 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, partial-thickness 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-shield/
KERECIS hf.
Diameter: 50mm
In Commercial Distribution

  • 05694310964326 ()
  • 05694310964319 ()

  • Outer Diameter: 50 Millimeter
50215I53B0D

  • Collagen wound matrix dressing
Fish-Skin Graft for Burn Wound Management. Kerecis® GraftGuide™ Mano is indicated for the management of wounds including: Partial and full thickness wounds, Trauma wounds including second degree burns, Surgical wounds including donor sites/ grafts. IFU: https://www.kerecis.com/ifus/ifu-kerecis-omega3-graftguide/
KERECIS hf.
Size L, 196 sq cm Dorsum Right / Palmar Left Meshed 2:1
In Commercial Distribution

  • 05694310964029 ()
  • 05694310964012 ()

  • Area/Surface Area: 196 Square centimeter
50202N36D0D

  • Collagen wound matrix dressing
Fish-Skin Graft for Burn Wound Management. Kerecis® GraftGuide™ Mano is indicated for the management of wounds including: Partial and full thickness wounds, Trauma wounds including second degree burns, Surgical wounds including donor sites/ grafts. IFU: https://www.kerecis.com/ifus/ifu-kerecis-omega3-graftguide/
KERECIS hf.
Size L, 196 sq cm Dorsum Left / Palmar Right Meshed 2:1
In Commercial Distribution

  • 05694310964005 ()
  • 05694310963992 ()

  • Area/Surface Area: 196 Square centimeter
50202N35D0D

  • Collagen wound matrix dressing
Fish-Skin Graft for Burn Wound Management. Kerecis® GraftGuide™ Mano is indicated for the management of wounds including: Partial and full thickness wounds, Trauma wounds including second degree burns, Surgical wounds including donor sites/ grafts. IFU: https://www.kerecis.com/ifus/ifu-kerecis-omega3-graftguide/
KERECIS hf.
Size M, 147 sq cm Dorsum Right / Palmar Left Meshed 2:1
In Commercial Distribution

  • 05694310963985 ()
  • 05694310963978 ()

  • Area/Surface Area: 147 Square centimeter
50202N34D0D

  • Collagen wound matrix dressing
Fish-Skin Graft for Burn Wound Management. Kerecis® GraftGuide™ Mano is indicated for the management of wounds including: Partial and full thickness wounds, Trauma wounds including second degree burns, Surgical wounds including donor sites/ grafts. IFU: https://www.kerecis.com/ifus/ifu-kerecis-omega3-graftguide/
KERECIS hf.
Size M, 147 sq cm Dorsum Left / Palmar Right Meshed 2:1
In Commercial Distribution

  • 05694310963954 ()
  • 05694310963961 ()

  • Area/Surface Area: 147 Square centimeter
50202N33D0D

  • Collagen wound matrix dressing
Fish-Skin Graft for Burn Wound Management. Kerecis® GraftGuide® is indicated for the management of wounds including: Partial and full thickness wounds, Trauma wounds including second degree burns, Surgical wounds including donor sites/ grafts. IFU: https://www.kerecis.com/ifus/ifu-kerecis-graftguide/
KERECIS hf.
Micro 114 sq cm
In Commercial Distribution

  • 05694310963947 ()
  • 05694310963930 ()

  • Area/Surface Area: 114 Square centimeter
50202P32D0D

  • Collagen 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 95 sq cm
In Commercial Distribution

  • 05694310963923 ()
  • 05694310963916 ()

  • Area/Surface Area: 95 Square centimeter
50205P31D0D

  • Collagen 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.
6x8 cm Meshed 2:1
In Commercial Distribution

  • 05694310963886 ()
  • 05694310963879 ()

  • Length: 6 Centimeter
  • Width: 4 Centimeter
50205N18D0D

  • Collagen 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.
4x6 cm Meshed 2:1
In Commercial Distribution

  • 05694310963848 ()
  • 05694310963831 ()

  • Width: 6 Centimeter
  • Length: 8 Centimeter
50205N20D0D

  • Collagen wound matrix dressing
Fish skin for surgical use. INTENDED USE Kerecis® SurgiBind™ is indicated for implantation to reinforce soft tissue where weakness exists in patients requiring soft tissue repair or reinforcement in plastic or reconstructive surgery. IFU: https://www.kerecis.com/ifus/ifu-kerecis-surgibind/
KERECIS hf.
3x20 cm
In Commercial Distribution

  • 05694310963800 ()
  • 05694310963794 ()

  • Width: 3 Centimeter
  • Length: 20 Centimeter
50241S19D0D

  • Extra-gynaecological surgical mesh, collagen, bioabsorbable, non-antimicrobial
Bilayer wound management medical device product made from fish skin and silicone. Kerecis® Shield™ Adhesive 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, partial-thickness 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-shield/
KERECIS hf.
30 mm Circular
In Commercial Distribution

  • 05694310963787 ()
  • 05694310963770 ()

  • Outer Diameter: 30 Millimeter
50215I52B0D

  • Collagen wound matrix dressing
Bilayer wound management medical device product made from fish skin and silicone. Kerecis® Shield™ Adhesive 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, partial-thickness 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-shield/
KERECIS hf.
20 mm Circular
In Commercial Distribution

  • 05694310963763 ()
  • 05694310963756 ()

  • Outer Diameter: 20 Millimeter
50215H51B0D

  • Collagen 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. https://www.kerecis.com/ifus/ifu-kerecis-marigen/
KERECIS hf.
7x10 cm
In Commercial Distribution

  • 05694310962445 ()
  • 05694310962438 ()

  • Length: 7 Centimeter
  • Width: 10 Centimeter
50200S03B0D

  • Collagen 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.
3x7 cm
In Commercial Distribution

  • 05694310962414 ()
  • 05694310962421 ()

  • Length: 3 Centimeter
  • Width: 7 Centimeter
50200S02B0D

  • Collagen 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.
3x3.5 cm
In Commercial Distribution

  • 05694310962391 ()
  • 05694310962407 ()

  • Length: 3 Centimeter
  • Width: 3.5 Centimeter
50200S01B0D

  • Collagen 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.
Expanse 8x10 cm
In Commercial Distribution

  • 05694310962247 ()
  • 05694310962230 ()
  • 05694310962261 ()

  • Length: 8 Centimeter
  • Width: 10 Centimeter
50200N13B0D

  • Collagen wound matrix dressing
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