BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    CORNEAL TREPHINE HANDLE

    DI: 00192896013209 · Model: 12-2269 · SONTEC INSTRUMENTS, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    CORNEAL TREPHINE HANDLE
    Primary DI
    00192896013209
    Version / Model
    12-2269
    Catalog Number
    12-2269
    Company Name
    SONTEC INSTRUMENTS, INC.
    Labeler DUNS
    040729840
    Distribution Status
    Not in Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2018-09-18
    Public Version
    2
    Public Version Date
    2023-07-26
    Public Version Status
    Update
    Public Device Record Key
    1bda2055-8973-42d9-a8ca-3f72be0c66ac
    Distribution End Date
    2023-07-25

    Device Description

    CORNEAL TREPHINE HANDLE

    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
    ["Dry Heat Sterilization", "Moist Heat or Steam Sterilization"]

    Product Codes

    Code Name
    HRH Trephine, manual, ophthalmic

    GMDN Terms

    Code Name
    14148 Corneal trephine, reusable

    Identifiers

    Type ID
    Primary 00192896013209

    Customer Contacts

    Phone
    +1(800) 821-7496
    Email
    [email protected]

    Device Sizes

    Type Value Unit Text
    Device Size Text, specify For 5.5 Millimeter Blade