BEUDAMED
    FDA Registration Active 🇺🇸 United States

    FortaDerm Wound Dressing

    Reg #: 1221816 · FEI: 1000148471 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    5
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    ORGANOGENESIS INC.
    Registration Number
    1221816
    FEI Number
    1000148471
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    150 DAN RD.
    City
    CANTON
    State
    MA
    ZIP
    02021
    Country
    US

    Regulatory Submissions

    510(k) Number
    K011026

    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
    Wound Dressing With Animal-Derived Material(S) KGN

    Proprietary Names

    FortaDerm Wound Dressing PuraPly Wound Matrix (2cm X 4cm) PuraPly Wound Matrix (5cm x 5cm) PuraPly Wound Matrix (6cm x 9cm) PuraPly Wound Matrix (25cm x 35cm)

    Establishment Types

    Manufacture Medical Device