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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® Shield™ Spiral - 05694310964364

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

Kerecis® Shield™ Standard - 05694310964319

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

Kerecis® Shield™ Adhesive - 05694310963770

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

Kerecis® Shield™ Adhesive - 05694310963756

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

CALICO - 00850044458677

Antimicrobial Super Sponge 4.5X4.1 Yards-6P,EO
Calico Medical Group LLC
SP001
In Commercial Distribution

  • 10850044458674 ()
  • 00850044458677 ()
SP001

  • Wound-nonadherent dressing, absorbent, antimicrobial

CALICO - 00850044458547

AG Silver Silicone Foam Dressing, Bordered, 6" x 6"
Calico Medical Group LLC
FD009
In Commercial Distribution

  • 20850044458541 ()
  • 00850044458547 ()
  • 10850044458544 ()
FD009

  • Cavity-wound management dressing, antimicrobial

CALICO - 00850044458530

AG Silver Silicone Foam Dressing, Bordered, 4" x 4"
Calico Medical Group LLC
FD008
In Commercial Distribution

  • 20850044458534 ()
  • 00850044458530 ()
  • 10850044458537 ()
FD008

  • Cavity-wound management dressing, antimicrobial

CALICO - 00850044458523

AG Silver Silicone Foam Dressing, Bordered, 2" x 2"
Calico Medical Group LLC
FD007
In Commercial Distribution

  • 20850044458527 ()
  • 00850044458523 ()
  • 10850044458520 ()
FD007

  • Cavity-wound management dressing, antimicrobial

INTEGRA® - 00650551033417

BREAST EXPANDER, CRESCENT, SMOOTH
PMT CORPORATION
3612-14L
In Commercial Distribution

  • 00650551033417 ()

  • Width: 10 Centimeter
  • Length: 14 Centimeter
  • Total Volume: 350 Centiliter
  • Projection 6 Centimeter
3612-14L

  • Skin-port tissue expander

INTEGRA® - 00650551033400

BREAST EXPANDER, TEARDROP, SMOOTH, INTERNAL PORT
PMT CORPORATION
3612-14I
In Commercial Distribution

  • 00650551033400 ()

  • Projection 7.5 Centimeter
  • Total Volume: 450 Centiliter
  • Length: 13 Centimeter
  • Width: 10 Centimeter
3612-14I

  • Skin-port tissue expander
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