BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    OP Response Spine System

    DI: 00840194422383 · Model: 03-1301-0010 · ORTHOPEDIATRICS CORP.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    OP Response Spine System
    Primary DI
    00840194422383
    Version / Model
    03-1301-0010
    Catalog Number
    03-1301-0010
    Company Name
    ORTHOPEDIATRICS CORP.
    Labeler DUNS
    796416191
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2023-04-30
    Public Version
    1
    Public Version Date
    2023-05-08
    Public Version Status
    New
    Public Device Record Key
    ed351791-5cec-4a08-9a89-cc820ce6f9b4

    Device Description

    5.5/6.0 Closed Screw Caddy 1

    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
    Yes
    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
    FSM TRAY, SURGICAL, INSTRUMENT

    GMDN Terms

    Code Name
    12143 Instrument tray, reusable

    Identifiers

    Type ID
    Primary 00840194422383