Address:150 DAN RD.,CANTON,MA,02021,US
Device Description : Apligraf is indicated for use with standard therapeutic compression for the trea Apligraf is indicated for use with standard therapeutic compression for the treatment of non-infected partial and full thickness skin ulcers due to venous insufficience of greater than one month duration and which have not adequately responded to conventional ulcer therapy. Apligraf is also indicated for use with standard diabetic foot ulcer care for the treatment of full-thickness neuropathic diabetic foot ulcers of greater than three weeks duration which have not adequately responded to conventional ulcer therapy and which extend through the dermis but without tendon, muscle, capsule or bone exposure.
Device Class : 3
Duns Number: 152165817
Premarket Exempt : No
Prescription Use : Yes
Device Description : Dermagraft is indicated for use in the treatment of full-thickness diabetic foot Dermagraft is indicated for use in the treatment of full-thickness diabetic foot ulcers greater than six weeks duration, which extend through the dermis, but without tendon, muscle, joint capsule, or bone exposure. Dermagraft should be used in conjunction with standard wound care regimens and in patients that have adequate blood supply to the involved foot.
Device Class : 3
Duns Number: 152165817
Premarket Exempt : No
Prescription Use : Yes
Device Description : PuraPly™ Wound Matrix consists of a single-layer fenestrated sheet of collagen i 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.
Device Class : U
Duns Number: 152165817
Premarket Exempt : No
Prescription Use : Yes
Device Description : PuraPly™ Antimicrobial Wound Matrix consists of a collagen sheet coated with pol 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.
Device Class : U
Duns Number: 152165817
Premarket Exempt : No
Prescription Use : Yes
Device Description : TRANSCYTE® is a human fibroblast-derived temporary skin substituteconsisting of TRANSCYTE® is a human fibroblast-derived temporary skin substituteconsisting of a polymer membrane and donated neonatal humanfibroblast cells cultured under aseptic conditions in vitro on a nylonmesh. Prior to cell growth, this nylon mesh is coated with porcinedermal collagen and bonded to a polymer membrane (silicone). Thismembrane provides a transparent synthetic epidermis when applied.As fibroblasts proliferate within the nylon mesh, they secrete humandermal collagen, matrix proteins and growth factors. Following freezing,no cellular metabolic activity remains; however, the tissue matrix andbound growth factors are left intact. The human fibroblast-derivedtemporary skin substitute provides a temporary protective barrier.TRANSCYTE is transparent and allows direct visual monitoring of thewound bed.
Device Class : 3
Duns Number: 152165817
Premarket Exempt : No
Prescription Use : Yes
Device Description : PuraPly™ Wound Matrix consists of a single-layer fenestrated sheet of collagen i 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.
Device Class :
Duns Number: 152165817
Premarket Exempt : No
Prescription Use : Yes
Device Description : PuraPly™ Wound Matrix consists of a single-layer fenestrated sheet of collagen i 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.
Device Class : U
Duns Number: 152165817
Premarket Exempt : No
Prescription Use : Yes
Device Description : PuraPly™ Wound Matrix consists of a single-layer fenestrated sheet of collagen i 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.
Device Class : U
Duns Number: 152165817
Premarket Exempt : No
Prescription Use : Yes
Device Description : PuraPly™ Antimicrobial Wound Matrix consists of a collagen sheet coated with pol 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.
Device Class : U
Duns Number: 152165817
Premarket Exempt : No
Prescription Use : Yes
Device Description : PuraPly™ Antimicrobial Wound Matrix consists of a collagen sheet coated with pol 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.
Device Class : U
Duns Number: 152165817
Premarket Exempt : No
Prescription Use : Yes