BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    N/A

    DI: 00817438022579 · Model: OK-121 · Omega Surgical Instruments Inc
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    N/A
    Primary DI
    00817438022579
    Version / Model
    OK-121
    Company Name
    Omega Surgical Instruments Inc
    Labeler DUNS
    808825038
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2022-08-08
    Public Version
    1
    Public Version Date
    2022-08-16
    Public Version Status
    New
    Public Device Record Key
    caf53d96-4ccb-4caf-8268-2bfe561f9f72

    Device Description

    15.0 MM X 6.4 MM X 1.02 MM SAGITTAL BLADE

    Device Characteristics

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

    Sterilization

    Is Sterile
    Yes
    Sterilization Prior Use
    Yes
    Sterilization Methods
    Radiation Sterilization

    Product Codes

    Code Name
    GFA Blade, Saw, General & Plastic Surgery, Surgical

    GMDN Terms

    Code Name
    43376 Surgical saw blade, sagittal, single-use

    Identifiers

    Type ID
    Primary 00817438022579

    Customer Contacts

    Phone
    8106959800
    Email
    [email protected]