BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Paul Banditt

    DI: D955OSTA61 · Model: OSTA6 · Terlain Enterprises, Inc.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Paul Banditt
    Primary DI
    D955OSTA61
    Version / Model
    OSTA6
    Company Name
    Terlain Enterprises, Inc.
    Labeler DUNS
    177465051
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2023-12-11
    Public Version
    1
    Public Version Date
    2023-12-19
    Public Version Status
    New
    Public Device Record Key
    b90ec818-693a-4be3-8090-c9bd0c52f3e0

    Device Description

    PAUL BANDITT EPKER A6 OSTEOTOME, 6MM CURVED, Marked @ 7,10,13,15,18,20

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    No
    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
    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
    EMM Chisel, Osteotome, Surgical

    GMDN Terms

    Code Name
    38168 Periosteal elevator, reusable

    Identifiers

    Type ID
    Primary D955OSTA61