BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Bite Fork Type SI / Fusion Bite

    DI: B915019603300 · Model: 01960330 · zebris MEDICAL GmbH
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Bite Fork Type SI / Fusion Bite
    Primary DI
    B915019603300
    Version / Model
    01960330
    Company Name
    zebris MEDICAL GmbH
    Labeler DUNS
    328971791
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2023-07-13
    Public Version
    1
    Public Version Date
    2023-07-21
    Public Version Status
    New
    Public Device Record Key
    3314201d-0d46-42d4-8ec0-b67e694071b7

    Device Description

    The Bite Fork is an accessory of the JMA+ facebow and used for temporary fixation of the lower jaw sensor to the maxilla.

    Device Characteristics

    Single Use
    No
    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
    Yes
    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
    Yes
    Sterilization Methods
    Moist Heat or Steam Sterilization

    Product Codes

    Code Name
    NFS Device, Jaw Tracking, For Monitoring Jaw Positions

    GMDN Terms

    Code Name
    35700 Facebow

    Identifiers

    Type ID
    Primary B915019603300

    Storage Conditions

    Type
    Storage Environment Temperature
    Temperature Range
    -20 – 70 Degrees Celsius