organo.comAPLIGRAF
ORGANOGENESIS, INC.
ORGANOGENESIS INC.
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 1221816 | 1000148471 | ORGANOGENESIS INC. | 1 | N | 2026-01-01 | 150 DAN RD. CANTON MA US 02021 |
| 2028403 | 1000096732 | Organogenesis Inc. | 1 | N | 2020-04-25 | 10933 North Torrey Pines Road La Jolla CA US 92037 |
GUDID Contact Samples#
| Source GUDID | Product | Phone | |
|---|---|---|---|
| 00618474000466 | PuraPly Antimicrobial XT Wound Matrix - 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. | 1-888-432-5232 | MEDINFO@ORGANO.COM |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 47543 | 1278722199 | K220317 | PuraPly Micronized Wound Matrix (PuraPly MZ) | KGN | 2022-07-01 |
| 47543 | 1468221914 | K051647 | FORTADERM ANTIMICROBIAL WOUND DRESSING | FRO | 2005-11-08 |
| 47543 | 1720608625 | K042809 | CUFFPATCH | FTM | 2004-11-02 |
| 47543 | 2015205918 | K011026 | FORTADERM WOUND DRESSING | KGN | 2001-06-13 |
| 47543 | 1534075029 | BP960700 | |||
| 167894 | 1534075029 | BP960700 | |||
| 47543 | 1176062913 | BP953200 | |||
| 47543 | 1330833758 | BP003600 | |||
| 167894 | 1330833758 | BP003600 |
Product Codes Associated With Registrations#
PMA#
APLIGRAF
ORGANOGENESIS, INC.
APLIGRAF
ORGANOGENESIS, INC.
APLIGRAF
ORGANOGENESIS, INC.
APLIGRAF
ORGANOGENESIS, INC.
APLIGRAF
ORGANOGENESIS, INC.
APLIGRAF
ORGANOGENESIS, INC.
APLIGRAF
ORGANOGENESIS, INC.
APLIGRAF
ORGANOGENESIS, INC.
APLIGRAF
ORGANOGENESIS, INC.
APLIGRAF
ORGANOGENESIS, INC.
APLIGRAF
ORGANOGENESIS, INC.
APLIGRAF
ORGANOGENESIS, INC.
APLIGRAF
ORGANOGENESIS, INC.
APLIGRAF
ORGANOGENESIS, INC.
APLIGRAF
ORGANOGENESIS, INC.
APLIGRAF
ORGANOGENESIS, INC.
APLIGRAF
ORGANOGENESIS, INC.
APLIGRAF
ORGANOGENESIS, INC.
APLIGRAF
ORGANOGENESIS, INC.
APLIGRAF
ORGANOGENESIS, INC.
APLIGRAF
ORGANOGENESIS, INC.
APLIGRAF
ORGANOGENESIS, INC.
APLIGRAF
ORGANOGENESIS, INC.
APLIGRAF
ORGANOGENESIS, INC.
APLIGRAF
ORGANOGENESIS, INC.
APLIGRAF
ORGANOGENESIS, INC.
APLIGRAF
ORGANOGENESIS, INC.
APLIGRAF
ORGANOGENESIS, INC.
APLIGRAF
ORGANOGENESIS, INC.
APLIGRAF
ORGANOGENESIS, INC.
APLIGRAF
ORGANOGENESIS, INC.
APLIGRAF
ORGANOGENESIS, INC.
APLIGRAF
ORGANOGENESIS, INC.
APLIGRAF
ORGANOGENESIS, INC.
APILGRAF
ORGANOGENESIS, INC.
APLIGRAF
ORGANOGENESIS, INC.
APLIGRAF
ORGANOGENESIS, INC.
APLIGRAF
ORGANOGENESIS, INC.
APLIGRAF
ORGANOGENESIS, INC.
PMN#
FortiShield (Biosynthetic Wound Matrix)
Organogenesis, Inc.
PuraPly Micronized Wound Matrix (PuraPly MZ)
Organogenesis Inc.
FORTAGEN ORAL MEMBRANE
ORGANOGENESIS, INC.
FORTADERM ANTIMICROBIAL WOUND DRESSING
ORGANOGENESIS, INC.
CUFFPATCH
ORGANOGENESIS, INC.
FORTAFLEX SURGICAL SLING
ORGANOGENESIS, INC.
FORTAFLEX SURGICAL MESH
ORGANOGENESIS, INC.
FORTAFLEX SURGICAL MESH
ORGANOGENESIS, INC.
FORTAFLEX SURGICAL MESH
ORGANOGENESIS, INC.
FORTADERM WOUND DRESSING
ORGANOGENESIS, INC.
FORTAFLEX SURGICAL SLING
ORGANOGENESIS, INC.
GRAFT PATCH
ORGANOGENESIS, INC.
GUDID#
PuraPly Antimicrobial XT Wound Matrix - 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.
2021-12-01
PuraPly Antimicrobial Wound Matrix - PuraPly Antimicrobial Wound Matrix is a cross-linked extracellular matrix (ECM) scaffolding that 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.
2026-03-12
PuraPly Antimicrobial Wound Matrix - PuraPly Antimicrobial Wound Matrix is a cross-linked extracellular matrix (ECM) scaffolding that 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.
2026-03-12
PuraPly Antimicrobial Wound Matrix - PuraPly Antimicrobial Wound Matrix is a cross-linked extracellular matrix (ECM) scaffolding that 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.
2026-03-12
PuraPly Antimicrobial Wound Matrix - PuraPly Antimicrobial Wound Matrix is a cross-linked extracellular matrix (ECM) scaffolding that 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.
2026-03-12
PuraPly Antimicrobial Wound Matrix - PuraPly Antimicrobial Wound Matrix is a cross-linked extracellular matrix (ECM) scaffolding that 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.
2026-03-12
PuraPly Antimicrobial Wound Matrix - PuraPly Antimicrobial Wound Matrix is a cross-linked extracellular matrix (ECM) scaffolding that 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.
2026-03-12
PuraPly Antimicrobial Wound Matrix - PuraPly Antimicrobial Wound Matrix is a cross-linked extracellular matrix (ECM) scaffolding that 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.
2026-03-12
PuraPly Antimicrobial Wound Matrix - PuraPly Antimicrobial Wound Matrix is a cross-linked extracellular matrix (ECM) scaffolding that 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.
2026-03-12
PuraPly Antimicrobial Surgical Wound Matrix - PuraPly Antimicrobial Surgical Wound Matrix is a cross-linked extracellular matrix (ECM) scaffolding that consists of a collagen sheet coated with 0.1% polyhexamethylenebiguanide hydrochloride (PHMB) intended for the management of wounds. PuraPly Antimicrobial Surgical Wound Matrix is supplied in a dry sheet form. The device is packaged in sterile, sealed single pouches.
2026-03-12
PuraPly Antimicrobial Surgical Wound Matrix - PuraPly Antimicrobial Surgical Wound Matrix is a cross-linked extracellular matrix (ECM) scaffolding that consists of a collagen sheet coated with 0.1% polyhexamethylenebiguanide hydrochloride (PHMB) intended for the management of wounds. PuraPly Antimicrobial Surgical Wound Matrix is supplied in a dry sheet form. The device is packaged in sterile, sealed single pouches.
2026-03-12
PuraPly Antimicrobial Surgical Wound Matrix - PuraPly Antimicrobial Surgical Wound Matrix is a cross-linked extracellular matrix (ECM) scaffolding that consists of a collagen sheet coated with 0.1% polyhexamethylenebiguanide hydrochloride (PHMB) intended for the management of wounds. PuraPly Antimicrobial Surgical Wound Matrix is supplied in a dry sheet form. The device is packaged in sterile, sealed single pouches.
2026-03-12
PuraPly Antimicrobial Surgical Wound Matrix - PuraPly Antimicrobial Surgical Wound Matrix is a cross-linked extracellular matrix (ECM) scaffolding that consists of a collagen sheet coated with 0.1% polyhexamethylenebiguanide hydrochloride (PHMB) intended for the management of wounds. PuraPly Antimicrobial Surgical Wound Matrix is supplied in a dry sheet form. The device is packaged in sterile, sealed single pouches.
2026-03-12
PuraPly™ Antimicrobial Wound Matrix - PuraPly Antimicrobial Wound Matrix is a cross-linked extracellular matrix (ECM) scaffolding that consists of a collagen sheet coated with 0.1% 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.
2021-04-06
PuraPly™ Antimicrobial Wound Matrix - 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.
2015-05-22
PuraPly™ Wound Matrix - 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.
2015-05-22
PuraPly™ Wound Matrix - 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.
2016-06-28
PuraPly™ Wound Matrix - 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.
2017-05-12
PuraPly Micronized Wound Matrix (PuraPly MZ) - PuraPly® Micronized Wound Matrix (PuraPly® MZ) consists of micronized porcine collagen intended for the management of wounds. PuraPly® Micronized Wound Matrix is supplied as a dry powder of particle size of less than or equal to 1000. The device is sterile and packaged in a vial sealed in a single pouch.
2023-05-01
PuraPly Micronized Wound Matrix (PuraPly MZ) - PuraPly® Micronized Wound Matrix (PuraPly® MZ) consists of micronized porcine collagen intended for the management of wounds. PuraPly® Micronized Wound Matrix is supplied as a dry powder of particle size of less than or equal to 1000. The device is sterile and packaged in a vial sealed in a single pouch.
2023-05-01
PuraPly Micronized Wound Matrix (PuraPly MZ) - PuraPly® Micronized Wound Matrix (PuraPly® MZ) consists of micronized porcine collagen intended for the management of wounds. PuraPly® Micronized Wound Matrix is supplied as a dry powder of particle size of less than or equal to 1000. The device is sterile and packaged in a vial sealed in a single pouch.
2023-05-01
PuraPly™ Antimicrobial Wound Matrix - 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.
2021-04-06
PuraPly™ Antimicrobial Wound Matrix - 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.
2020-10-02
PuraForce™ - 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.
2019-07-17
PuraForce ™ - 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.
2019-07-17
PuraForce™ - 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.
2019-07-17
PuraForce™ - 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.
2019-07-17
PuraPly™ Antimicrobial XT Wound Matrix - 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.
2019-10-01
PuraPly™ Antimicrobial XT Wound Matrix - 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.
2019-10-01
PuraPly™ Wound Matrix - 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.
2016-03-24
PuraPly™ Wound Matrix - 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.
2016-04-27
PuraPly™ Antimicrobial Wound Matrix - 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.
2016-03-18
PuraPly™ Antimicrobial Wound Matrix - 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.
2016-03-24
PuraPly™ Antimicrobial Wound Matrix - 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.
2016-03-23
PuraPly™ Antimicrobial Wound Matrix - 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.
2016-03-28
PuraPly™ Antimicrobial Wound Matrix - 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.
2016-11-16
PuraPly™ Wound Matrix - 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.
2017-05-12
TransCyte - 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.
2018-01-12
PuraPly™ Antimicrobial XT Wound Matrix - 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.
2019-10-01
Dermagraft - 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.
2014-09-24