BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    Set OSSEODOC + BASCH-1 + Pump

    DI: J00717005250011 · Model: 1700525 · Bien-Air Surgery SA
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Set OSSEODOC + BASCH-1 + Pump
    Primary DI
    J00717005250011
    Version / Model
    1700525
    Catalog Number
    1700525-001
    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
    2
    Public Version Date
    2023-02-13
    Public Version Status
    Update
    Public Device Record Key
    24f04121-d0e6-4a49-8330-4c44d1551631
    Distribution End Date
    2023-02-10

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    Yes
    Over the Counter (OTC)
    No
    Kit
    Yes
    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
    Yes
    Sterilization Methods
    Moist Heat or Steam Sterilization

    Product Codes

    Code Name
    ERL Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece

    GMDN Terms

    Code Name
    41264 Surgical power tool system control unit, line-powered

    Identifiers

    Type ID
    Primary J00717005250011

    Premarket Submissions

    Submission Number Supplement Number
    K792159 000