BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Mainster Wide Filed EX

    DI: 00630238123020 · Model: OMRA-WFEX · OCULAR INSTRUMENTS, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Mainster Wide Filed EX
    Primary DI
    00630238123020
    Version / Model
    OMRA-WFEX
    Company Name
    OCULAR INSTRUMENTS, INC.
    Labeler DUNS
    046212387
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2019-06-11
    Public Version
    1
    Public Version Date
    2019-06-19
    Public Version Status
    New
    Public Device Record Key
    75877496-36fb-49a4-a6d2-756edf420c5d

    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
    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
    High-level Disinfectant

    Product Codes

    Code Name
    HJK Lens, Contact, Polymethylmethacrylate, Diagnostic

    GMDN Terms

    Code Name
    58037 Vitrectomy contact lens, reusable

    Identifiers

    Type ID
    Direct Marking 00630238123310
    Primary 00630238123020