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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Endoform™ Antimicrobial is a 100% w/w intact extracellular matrix (ECM), manufactured from ovine (sheep) forestomach tissue and incorporating approximately 12 ug/cm2 (~0.3% w/w) ionic silver, intended to inhibit colonization of the device. This advanced wound care device retains the innate biological structure of the native ECM, along with associated macromolecules including elastin, fibronectin, glycosaminoglycans and laminin. When rehydrated with exudate or sterile saline, Endoform Antimicrobial transforms into a soft conforming sheet, which is naturally incorporated into the wound over time.
AROA BIOSURGERY LIMITED
629302
In Commercial Distribution

  • 09421906017427 ()
  • 09421906017595 ()

  • 5 x 5 cm - 2 x 2"


  • Animal-derived wound matrix dressing
PuraPly™ Antimicrobial XT Wound Matrix consists of a collagen sheet coated with 0.1% polyhexamethylenebiguanide hydrochloride (PHMB) intended for the management of wounds. PuraPly™ Antimicrobial XT Wound Matrix is supplied dry in sheet form. The device is packaged in sterile, sealed single pouches.
ORGANOGENESIS INC.
515-017
In Commercial Distribution

  • 00618474000466 ()

  • Width: 4.91 Centimeter
  • Length: 4.91 Centimeter


  • Animal-derived wound matrix dressing
uraPly™ Antimicrobial Wound Matrix (fenestrated) consists of a collagen sheet coated with polyhexamethylenebiguanide hydrochloride (PHMB) intended for the management of wounds. PuraPly™ Antimicrobial Wound Matrix is supplied dry in sheet form. The device is packaged in sterile, sealed single pouches.
ORGANOGENESIS INC.
515-067
Not in Commercial Distribution

  • 00618474000442 ()

  • Width: 3 Centimeter
  • Length: 4 Centimeter


  • Animal-derived wound matrix dressing
PuraPly™ Antimicrobial Wound Matrix consists of collagen sheets coated with polyhexamethylenebiguanide hydrochloride (PHMB) intended for the management of wounds. PuraPly™ Antimicrobial Wound Matrix is supplied dry in sheet form. The device is packaged in sterile, sealed pouches.
ORGANOGENESIS INC.
515-069
In Commercial Distribution

  • 00618474000459 ()

  • Width: 4 Centimeter
  • Length: 4 Centimeter


  • Animal-derived wound matrix dressing
PuraPly™ Antimicrobial Wound Matrix consists of collagen sheets coated with polyhexamethylenebiguanide hydrochloride (PHMB) intended for the management of wounds. PuraPly™ Antimicrobial Wound Matrix is supplied dry in sheet form. The device is packaged in sterile, sealed pouches.
ORGANOGENESIS INC.
515-065
In Commercial Distribution

  • 00618474000435 ()

  • Length: 3 Centimeter
  • Width: 4 Centimeter


  • Animal-derived wound matrix dressing
PuraPly™ Antimicrobial XT Wound Matrix consists of a collagen sheet coated with 0.1% polyhexamethylenebiguanide hydrochloride (PHMB) intended for the management of wounds. PuraPly™ Antimicrobial XT Wound Matrix is supplied dry in sheet form. The device is packaged in sterile, sealed single pouches.
ORGANOGENESIS INC.
515-036
In Commercial Distribution

  • 00618474000282 ()

  • Width: 9 Centimeter
  • Length: 6 Centimeter


  • Animal-derived wound matrix dressing
PuraPly™ Wound Matrix consists of a single-layer fenestrated sheet of collagen intended for the management of wounds. PuraPly™ Wound Matrix is supplied dry in sheet form. The device is packaged in sterile, sealed single pouches.
ORGANOGENESIS INC.
515-024
In Commercial Distribution

  • 00618474000152 ()
  • 00618474000145 ()

  • Width: 3.05 Centimeter
  • Length: 2.05 Centimeter


  • Animal-derived wound matrix dressing
PuraPly™ Antimicrobial Wound Matrix consists of a collagen sheet coated with polyhexamethylenebiguanide hydrochloride (PHMB) intended for the management of wounds. PuraPly™ Antimicrobial Wound Matrix is supplied dry in sheet form. The device is packaged in sterile, sealed pouches.
ORGANOGENESIS INC.
515-020
In Commercial Distribution

  • 00618474000121 ()

  • Width: 16 Centimeter
  • Length: 8 Centimeter


  • Animal-derived wound matrix dressing
PuraPly™ Antimicrobial Wound Matrix consists of a collagen sheet coated with polyhexamethylenebiguanide hydrochloride (PHMB) intended for the management of wounds. PuraPly™ Antimicrobial Wound Matrix is supplied dry in sheet form. The device is packaged in sterile, sealed single pouches.
ORGANOGENESIS INC.
515-018
In Commercial Distribution

  • 00618474000114 ()

  • Width: 9 Centimeter
  • Length: 6 Centimeter


  • Animal-derived wound matrix dressing
PuraPly™ Antimicrobial Wound Matrix consists of a collagen sheet coated with polyhexamethylenebiguanide hydrochloride (PHMB) intended for the management of wounds. PuraPly™ Antimicrobial Wound Matrix is supplied dry in sheet form. The device is packaged in sterile, sealed single pouches.
ORGANOGENESIS INC.
515-008
In Commercial Distribution

  • 00618474000107 ()

  • Width: 5 Centimeter
  • Length: 5 Centimeter


  • Animal-derived wound matrix dressing
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