BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Gilras

    DI: 00851158007478 · Model: GR-1500 · U.S. OPHTHALMIC, L.L.C.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Gilras
    Primary DI
    00851158007478
    Version / Model
    GR-1500
    Company Name
    U.S. OPHTHALMIC, L.L.C.
    Labeler DUNS
    166760392
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2017-02-02
    Public Version
    2
    Public Version Date
    2018-03-29
    Public Version Status
    Update
    Public Device Record Key
    7615c077-ee20-40e9-bde4-c7ac9469d6c8

    Device Description

    Gilras GR-1500 Manual Refractor

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

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    HKN Refractor, Manual, Non-Powered, Including Phoropter

    GMDN Terms

    Code Name
    36387 Ophthalmic refractometer, manual

    Identifiers

    Type ID
    Primary 00851158007478