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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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PuraForce ™ tendon reinforcement matrix is a resorbable collagen based material intended for implantation to reinforce soft tissue. The device is supplied sterile in double layer peel-open packaging. The product is packaged hydrated and is ready to use. PuraForce ™ is intended for reinforcement of soft tissues repaired by sutures or suture anchors, during tendon repair surgery including reinforcement of rotator cuff, patellar, Achilles, biceps and quadriceps or other tendons. PuraForce ™ is not intended to replace normal body structure or provide the full mechanical strength to support the rotator cuff, patellar, Achilles, biceps and quadriceps tendons. Sutures, used to repair the tear, and sutures or bone anchors, used to attach the tissue to the bone, provide biomechanical strength for the tendon repair. PuraForce reinforces soft tissue and provides a resorbable scaffold that is replaced by the patient’s own soft tissue.
ORGANOGENESIS INC.
550-002
In Commercial Distribution

  • 00618474000206 ()

  • Width: 2 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
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.
515-016
In Commercial Distribution

  • 00618474000091 ()

  • Width: 4 Centimeter
  • Length: 2 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.
515-014
In Commercial Distribution

  • 00618474000084 ()

  • Width: 2 Centimeter
  • Length: 2 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.
515-012
In Commercial Distribution


  • 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.
515-006
In Commercial Distribution

  • 00618474000060 ()

  • Width: 5 Centimeter
  • Length: 5 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.
515-010
In Commercial Distribution

  • 00618474000053 ()
  • 00618474000138 ()

  • Width: 4 Centimeter
  • Length: 2 Centimeter


  • Animal-derived wound matrix dressing
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