BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    ELEVATOR, 5mm PERIOSTEAL

    DI: 00848665030013 · Model: 0911-100 · ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
    View on AccessGUDID
    Product Codes
    2
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    ELEVATOR, 5mm PERIOSTEAL
    Primary DI
    00848665030013
    Version / Model
    0911-100
    Company Name
    ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
    Labeler DUNS
    117858154
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2020-10-23
    Public Version
    2
    Public Version Date
    2020-12-04
    Public Version Status
    Update
    Public Device Record Key
    8b97734f-8f7e-44dc-8e3b-e2c80c4717bb

    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
    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
    HWC Screw, Fixation, Bone
    HRS Plate, Fixation, Bone

    GMDN Terms

    Code Name
    38168 Periosteal elevator, reusable

    Identifiers

    Type ID
    Primary 00848665030013

    Customer Contacts

    Phone
    3105339966
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K161913 000