BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    ENDOSKELETON Sterile Barrier System

    DI: M682113010100 · Model: 1130-1010 · TITAN SPINE, LLC
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    ENDOSKELETON Sterile Barrier System
    Primary DI
    M682113010100
    Version / Model
    1130-1010
    Catalog Number
    1130-1010
    Company Name
    TITAN SPINE, LLC
    Labeler DUNS
    623316978
    Distribution Status
    Not in Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-09-17
    Public Version
    10
    Public Version Date
    2022-09-16
    Public Version Status
    Update
    Public Device Record Key
    04f450ba-0c54-4ba0-b928-15fbbd5a5c2d
    Distribution End Date
    2020-09-21

    Device Description

    Caddy, Large

    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
    Yes
    PM Exempt
    Yes
    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
    LXH ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

    GMDN Terms

    Code Name
    12143 Instrument tray, reusable

    Identifiers

    Type ID
    Primary M682113010100

    Customer Contacts

    Phone
    +1(262)242-7801
    Email
    [email protected]

    Device Sizes

    Type Value Unit Text
    Device Size Text, specify Caddy, Large