BEUDAMED
    FDA Registration Active 🇺🇸 United States

    DynaGinate AG Silver Calcium Alginate Dressing 2"x2"

    Reg #: 3012100095 · FEI: 3012100095 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    3
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    ORGANOGENESIS INC.
    Registration Number
    3012100095
    FEI Number
    3012100095
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    12495 34th Street North, Suite D
    City
    Saint Petersburg
    State
    FL
    ZIP
    33716
    Country
    US

    Regulatory Submissions

    510(k) Number
    K120181

    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
    Dressing, Wound, Drug FRO

    Proprietary Names

    DynaGinate AG Silver Calcium Alginate Dressing 2"x2" DynaGinate AG Silver Calcium Alginate Rope Dressings DynaGinate AG Silver Calcium Alginate Dressing 4"x5"

    Establishment Types

    Repack or Relabel Medical Device Complaint File Establishment per 21 CFR 820.198