BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Bismuth Tribromophenate in a Petrolatum Blend Xeroform

    Reg #: 3012100095 · FEI: 3012100095 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    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
    K152970

    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

    Bismuth Tribromophenate in a Petrolatum Blend Xeroform

    Establishment Types

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