Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1221816

FEI Number

1000148471

Entity Name

ORGANOGENESIS INC.

City/State/Country

CANTON, MA, US

Establishment Address

150 DAN RD., CANTON, MA 02021, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Organogenesis Inc. (Owner Number: 9008375)

Owner / Operator Contact Address

150 Dan Road, --, Canton, MA 02021, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

BP960700

All Registered Proprietary Names

PuraForce 8cm x 4cm (Previously known as CuffPatch and Inforce) PuraForce 6cm x 3cm (Previously known as CuffPatch and Inforce) PuraForce 6.5cm x 9cm (Previously known as CuffPatch and Inforce) PuraForce 6cm x 2cm (Previously known as CuffPatch and Inforce) FortaDerm Antimicrobial Wound Dressing PuraPly Antimicrobial Wound Matrix (6cm x 9cm) PuraPly Antimicrobial Wound Matrix (2cm x 2cm) PuraPly Antimicrobial Wound Matrix (2cm x 4cm) PuraPly Antimicrobial Wound Matrix (8cm x 16cm) PuraPly Antimicrobial Wound Matrix (5cm x 5cm) PuraPly Antimicrobial Wound Matrix (4cm x 4cm) PuraPly Antimicrobial Wound Matrix (3.76cm x 3.76cm) PuraPly Antimicrobial Wound Matrix (32cm x 32cm) PuraPly Antimicrobial Wound Matrix (25cm x 35cm) PuraPly Antimicrobial Wound Matrix (3X4) PuraPly Antimicrobial Wound Matrix (1.25cm x 20cm) PuraPly Antimicrobial Wound Matrix (1.6cm Disc) PuraPly Antimicrobial XT Wound Matrix (6cm x 9cm) PuraPly Antimicrobial XT Wound Matrix (5cm x 5cm) PuraPly Antimicrobial Wound Matrix (1.4cm Disc) PuraPly Antimicrobial Wound Matrix (1.88cm x 1.88cm) PuraPly Antimicrobial Wound Matrix (3cmX4cm) PuraPly Antimicrobial XT Wound Matrix (4.91cm x 4.91cm) PuraPly Antimicrobial Surgical Wound Matrix (6cm x 9cm) (PuraPly SX) PuraPly Antimicrobial Surgical Wound Matrix (5cm x 5cm) (PuraPly SX) PuraPly Wound Matrix (2cm X 4cm) FortaDerm Wound Dressing PuraPly Wound Matrix (5cm x 5cm) PuraPly Wound Matrix (6cm x 9cm) PuraPly Wound Matrix (25cm x 35cm) Apligraf PuraPly® Micronized Wound Matrix (PuraPly® MZ TransCyte

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FTM	Mesh, Surgical	General, Plastic Surgery	Class 2	878.3300	2007-11-27
FRO	Dressing, Wound, Drug	Unknown	Class U	N/A	2015-02-05
KGN	Wound Dressing With Animal-Derived Material(S)	Unknown	Class U	N/A	2015-02-05
PFC	Cultured Human Cell Skin Dressing	Unknown	Class 3	N/A	2016-01-18
KGN	Wound Dressing With Animal-Derived Material(S)	Unknown	Class U	N/A	2022-07-13
MGR	Dressing, Wound And Burn, Interactive	Unknown	Class 3	N/A	2017-01-26

Official Correspondent

Patrick Bilbo

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Organogenesis Inc.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K134033	Miromatrix Medical, Inc.	MIROMATRIX BIOLOGICAL MESH	2014-03-31
K150256	Argentum Medical	SILVERLON BURN CONTACT DRESSINGS	2015-04-30
K112888	Kensey Nash Corporation	MESO WOUND MATRIX	2012-02-10
K040211	Collagen Matrix, Inc.	MODIFICATION TO: COLLAGEN TOPICAL WOUND DRESSING	2004-02-27

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0039-2020	AZIYO BIOLOGICS	2	BioEnvelope, surgical mesh envelope. Labeled as the following: 1. BioEnvelope (Medium) (single pack); 2. BioEnvelope (Large) (single pack); 3. BioEnvelope (Extra Large) (single pack); 4. BioEnvelope (Extra Extra Large) (single pack); 5. BioEnvelope (Large) (5-pack); 6. BioEnvelope (Medium) (5-pack); 7. BioEnvelope (Extra Extra Large) (5-pack); 8. BioEnvelope (Extra Large) (5-pack) Product Usage: The BioEnvelope is intended to securely hold a cardiac implantable electronic device to create a stable environment when implanted in the body. The cardiac implantable electronic devices that may be used with the CanGaroo Envelope include pacemaker pulse generators, defibrillators, or other cardiac implantable electronic devices.
Z-0040-2020	AZIYO BIOLOGICS	2	CanGaroo Envelopes labeled as the following: 1. CanGaroo Envelope (Large) (single pack); 2. CanGaroo Envelope (Medium) (single pack); 3. CanGaroo Envelope (Extra Large) (single pack); 4. CanGaroo Envelope (Extra Extra Large) (single pack); 5. CanGaroo Envelope (Large) (5 pack); 6. CanGaroo Envelope (Medium) (5 pack); 7. CanGaroo Envelope (Extra Large) (5 pack); 8. CanGaroo Envelope (Extra Extra Large) (5 pack) Product Usage: The CanGaroo Envelope is intended to securely hold a cardiac implantable electronic device or an implantable neurostimulator to create a stable environment when implanted in the body. The cardiac implantable electronic devices that may be used with the CanGaroo Envelope include pacemaker pulse generators, defibrillators, or other cardiac implantable electronic devices. The implantable neurostimulator devices that may be used with the CanGaroo Envelope include vagus nerve stimulators, spinal cord neuromodulators, deep brain stimulators and sacral nerve stimulators.
Z-0003-06	B. Braun Medical, Inc.	U	D-Stat Dry Hemostatic Bandage. The product is an adhesive bandage.
Z-0038-2025	3M Company Health Care Business 3m Center	U	3M Tegaderm CHG, Chlorhexidine Gluconate I.V. Securement Dressing, REF 1658R

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1221816. Last updated year: 2026. Please use registration number 1221816 when referencing this establishment in official correspondence.