BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Biomet OrthoPak Non-invasive Stimulator

    DI: 00812301020409 · Model: 1067783-1 · EBI, LLC
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Biomet OrthoPak Non-invasive Stimulator
    Primary DI
    00812301020409
    Version / Model
    1067783-1
    Catalog Number
    1067783-1
    Company Name
    EBI, LLC
    Labeler DUNS
    050410323
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2014-09-19
    Public Version
    4
    Public Version Date
    2022-03-10
    Public Version Status
    Update
    Public Device Record Key
    bb8c965d-b750-454d-a961-07481a366854

    Device Description

    BATTERY DOOR, BIOMET ORTHOPAK REPLACEMENT

    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
    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
    Yes
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    LOF Stimulator, Bone Growth, Non-Invasive

    GMDN Terms

    Code Name
    35463 Patient-worn bone growth electromagnetic stimulator

    Identifiers

    Type ID
    Primary 00812301020409

    Customer Contacts

    Phone
    1.973.299.9300
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    P850022 017