BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    N/A

    DI: 00889095057560 · Model: 685.027S · GLOBUS MEDICAL, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    N/A
    Primary DI
    00889095057560
    Version / Model
    685.027S
    Company Name
    GLOBUS MEDICAL, INC.
    Labeler DUNS
    139105691
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2021-03-19
    Public Version
    1
    Public Version Date
    2021-03-29
    Public Version Status
    New
    Public Device Record Key
    725c2fad-4571-46b5-8d19-b48bc4e992cb

    Device Description

    REVOLVE Bone Access Needle, 8G, Trocar Tip

    Device Characteristics

    Single Use
    Yes
    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
    Yes
    Has Manufacturing Date
    No
    Has Expiration Date
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    Yes
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    LXH ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

    GMDN Terms

    Code Name
    35210 Exploratory blunt needle, single-use

    Identifiers

    Type ID
    Primary 00889095057560