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    FDA UDI In Commercial Distribution 🇺🇸 United States

    EVA TDC Vitrectomy Pack Gravity Input 27G

    DI: 08717872032221 · Model: 8310.27G11 · D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.
    View on AccessGUDID
    Product Codes
    3
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    6

    Basic Information

    Brand Name
    EVA TDC Vitrectomy Pack Gravity Input 27G
    Primary DI
    08717872032221
    Version / Model
    8310.27G11
    Company Name
    D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.
    Labeler DUNS
    407522184
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    6
    Record Status
    Published
    Publish Date
    2022-12-08
    Public Version
    1
    Public Version Date
    2022-12-16
    Public Version Status
    New
    Public Device Record Key
    47d518fb-3e8c-47e4-9b68-707b4cd62d8a

    Device Characteristics

    Single Use
    Yes
    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
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    Yes
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    HQC Unit, Phacofragmentation
    HQE Instrument, Vitreous Aspiration And Cutting, Ac-Powered
    HQF Laser, Ophthalmic

    GMDN Terms

    Code Name
    45150 Ophthalmic surgical procedure kit, non-medicated, single-use

    Identifiers

    Type ID
    Unit of Use 18717872032228
    Primary 08717872032221

    Premarket Submissions

    Submission Number Supplement Number
    K190875 000