BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    BiOM T2

    DI: 04032767811571 · Model: 757B16 · OTTO BOCK HEALTHCARE
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    1

    Basic Information

    Brand Name
    BiOM T2
    Primary DI
    04032767811571
    Version / Model
    757B16
    Company Name
    OTTO BOCK HEALTHCARE
    Labeler DUNS
    932133408
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2018-04-11
    Public Version
    3
    Public Version Date
    2023-05-03
    Public Version Status
    Update
    Public Device Record Key
    ad7d7390-5990-4175-b089-8cba5b636e08

    Device Description

    BiOM T2 Battery

    Device Characteristics

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

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    ISW Assembly, Knee/Shank/Ankle/Foot, External

    GMDN Terms

    Code Name
    36534 Portable/mobile rechargeable battery pack

    Identifiers

    Type ID
    Previous B15520015960
    Primary 04032767811571