BEUDAMED
    FDA Registration Active 🇺🇸 United States

    ORGANOGENESIS INC.

    Reg #: 1221816 · FEI: 1000148471 · Expires 2026
    View on FDA
    Products
    5
    Proprietary Names
    34
    Establishment Types
    2
    Classifications
    5

    Registration Details

    Registration Name
    ORGANOGENESIS INC.
    Registration Number
    1221816
    FEI Number
    1000148471
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    150 DAN RD.
    City
    CANTON
    State
    MA
    ZIP
    02021
    Country
    US

    Regulatory Submissions

    510(k) Number
    K042809
    PMA Number
    BP953200

    Owner / Operator

    Firm Name
    Organogenesis Inc.
    Operator Number
    9008375
    Address
    150 Dan Road, --
    City
    Canton
    State
    MA
    Postal Code
    02021
    Country
    US
    Correspondent
    Patrick R Bilbo

    Products

    Device Name Product Code
    Mesh, Surgical FTM
    Dressing, Wound, Drug FRO
    Wound Dressing With Animal-Derived Material(S) KGN
    Cultured Human Cell Skin Dressing PFC
    Dressing, Wound And Burn, Interactive MGR

    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 Dermagraft

    Establishment Types

    Manufacture Medical Device Complaint File Establishment per 21 CFR 820.198