BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Tolentino 30° Prism Vitrectomy Lens

    DI: 00630238008440 · Model: OLV-7 · OCULAR INSTRUMENTS, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Tolentino 30° Prism Vitrectomy Lens
    Primary DI
    00630238008440
    Version / Model
    OLV-7
    Company Name
    OCULAR INSTRUMENTS, INC.
    Labeler DUNS
    046212387
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-12-12
    Public Version
    3
    Public Version Date
    2018-10-17
    Public Version Status
    Update
    Public Device Record Key
    481abf97-fb9f-49aa-b696-6698b9c88a6c

    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
    Yes
    PM Exempt
    No
    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
    HJK Lens, Contact, Polymethylmethacrylate, Diagnostic

    GMDN Terms

    Code Name
    58037 Vitrectomy contact lens, reusable

    Identifiers

    Type ID
    Primary 00630238008440