BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Intacs Inspection Gauge

    DI: 00850048576025 · Model: KV10732 · ADDITION TECHNOLOGY, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Intacs Inspection Gauge
    Primary DI
    00850048576025
    Version / Model
    KV10732
    Company Name
    ADDITION TECHNOLOGY, INC.
    Labeler DUNS
    118496814
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2023-06-13
    Public Version
    1
    Public Version Date
    2023-06-21
    Public Version Status
    New
    Public Device Record Key
    a946ff13-0791-42e3-a56c-0cfced00f790

    Device Description

    The Inspection Gauge, 0.9 mm is used as a reference to inspect the concentricity and planarity of the 0.9 mm CW and CCW Corneal Separators prior to each Intacs Corneal Implants surgery.

    Device Characteristics

    Single Use
    No
    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
    No
    Has Donation ID
    No

    Sterilization

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

    Product Codes

    Code Name
    HND Spatula, Ophthalmic

    GMDN Terms

    Code Name
    39610 General-purpose surgical spatula

    Identifiers

    Type ID
    Primary 00850048576025