BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Sentient Manufacturing

    DI: 00860007603785 · Model: 3041140 · Sentient Manufacturing, LLC
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    100

    Basic Information

    Brand Name
    Sentient Manufacturing
    Primary DI
    00860007603785
    Version / Model
    3041140
    Company Name
    Sentient Manufacturing, LLC
    Labeler DUNS
    106674754
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    100
    Record Status
    Published
    Publish Date
    2022-09-16
    Public Version
    3
    Public Version Date
    2023-08-01
    Public Version Status
    Update
    Public Device Record Key
    f40c6c7b-44f2-4f2d-b8f7-60fc7a40f403

    Device Description

    Laser Fiber Borst Silicone Inserts (100)

    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
    No
    Has Serial Number
    No
    Has Lot/Batch Number
    Yes
    Has Manufacturing Date
    No
    Has Expiration Date
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    Yes
    Sterilization Methods
    Moist Heat or Steam Sterilization

    Product Codes

    Code Name
    GEX Powered Laser Surgical Instrument

    GMDN Terms

    Code Name
    62600 General/multiple surgical laser system beam guide, single-use

    Identifiers

    Type ID
    Primary 00860007603785
    Unit of Use 00860008856418