BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    Cranio Guard 15mm rotating

    DI: J00716008790011 · Model: 1600879 · Bien-Air Surgery SA
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Cranio Guard 15mm rotating
    Primary DI
    J00716008790011
    Version / Model
    1600879
    Catalog Number
    1600879-001
    Company Name
    Bien-Air Surgery SA
    Labeler DUNS
    481597719
    Distribution Status
    Not in Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2019-01-07
    Public Version
    3
    Public Version Date
    2023-12-04
    Public Version Status
    Update
    Public Device Record Key
    8bc096cd-e5eb-46ba-bd3e-fd6460ca5ac0
    Distribution End Date
    2023-02-09

    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
    No
    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
    Yes
    Sterilization Methods
    Moist Heat or Steam Sterilization

    Product Codes

    Code Name
    HBC Motor, Drill, Electric

    GMDN Terms

    Code Name
    42981 Trephining power tool attachment

    Identifiers

    Type ID
    Direct Marking J00716008790
    Primary J00716008790011