FDA.reportPublic FDA data

ORGANOGENESIS INC.

Matched from indexed company URL: Organogenesis, Inc.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
12218161000148471ORGANOGENESIS INC.1N2026-01-01150 DAN RD. CANTON MA US 02021
20284031000096732Organogenesis Inc.1N2020-04-2510933 North Torrey Pines Road La Jolla CA US 92037

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
00618474000466PuraPly 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.1-888-432-5232MEDINFO@ORGANO.COM

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
475431278722199K220317PuraPly Micronized Wound Matrix (PuraPly MZ)KGN2022-07-01
475431468221914K051647FORTADERM ANTIMICROBIAL WOUND DRESSINGFRO2005-11-08
475431720608625K042809CUFFPATCHFTM2004-11-02
475432015205918K011026FORTADERM WOUND DRESSINGKGN2001-06-13
475431534075029BP960700
1678941534075029BP960700
475431176062913BP953200
475431330833758BP003600
1678941330833758BP003600

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
KGN22022-07-01
FRO12005-11-08
FTM12004-11-02

PMA#

67 records. Showing 1-40. Next

PMN#

GUDID#

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.

ORGANOGENESIS INC.

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.

ORGANOGENESIS INC.

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.

ORGANOGENESIS INC.

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.

ORGANOGENESIS INC.

2019-07-17

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.

ORGANOGENESIS INC.

2018-01-12

41 records. Showing 1-40. Next