BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    ColActive Plus AG 4x4 300/cs

    DI: 00825439010105 · Model: 10340000 · HARTMANN USA, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    3
    Pkg Device Count
    1

    Basic Information

    Brand Name
    ColActive Plus AG 4x4 300/cs
    Primary DI
    00825439010105
    Version / Model
    10340000
    Company Name
    HARTMANN USA, INC.
    Labeler DUNS
    010137511
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2020-09-01
    Public Version
    4
    Public Version Date
    2023-06-26
    Public Version Status
    Update
    Public Device Record Key
    a8ebecfb-860a-4e6a-a152-e40ca4b71f53

    Device Description

    ColActive Plus AG 4x4 300/cs

    Device Characteristics

    Single Use
    Yes
    Prescription Use (Rx)
    Yes
    Over the Counter (OTC)
    No
    Kit
    No
    Combination Product
    No
    HCT/P
    No
    Contains NRL
    No
    Not Made with NRL
    Yes
    MRI Safety
    Labeling does not contain MRI Safety Information
    Direct Marking Exempt
    No
    PM Exempt
    No
    Has Serial Number
    No
    Has Lot/Batch Number
    Yes
    Has Manufacturing Date
    Yes
    Has Expiration Date
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    Yes
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    FRO Dressing, Wound, Drug

    GMDN Terms

    Code Name
    45023 Collagen wound matrix dressing

    Identifiers

    Type ID
    Primary 00825439010105
    Package 00825439010235
    Package 10825439010249

    Premarket Submissions

    Submission Number Supplement Number
    K060804 000