BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    case sticker

    DI: 04032767761401 · Model: 9001L05 · Otto Bock Healthcare Products GmbH
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    case sticker
    Primary DI
    04032767761401
    Version / Model
    9001L05
    Company Name
    Otto Bock Healthcare Products GmbH
    Labeler DUNS
    300802068
    Distribution Status
    Not in Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-09-23
    Public Version
    9
    Public Version Date
    2023-06-02
    Public Version Status
    Update
    Public Device Record Key
    331a029a-cda4-463a-8e20-23b0ae654feb
    Distribution End Date
    2020-03-18

    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
    No
    Has Serial Number
    No
    Has Lot/Batch Number
    Yes
    Has Manufacturing Date
    No
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    IPF Stimulator, Muscle, Powered

    GMDN Terms

    Code Name
    46573 Physical therapy transcutaneous neuromuscular electrical stimulation system

    Identifiers

    Type ID
    Primary 04032767761401

    Premarket Submissions

    Submission Number Supplement Number
    K080950 000