BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    CUSTOM TDC VITREC.PACK VGP 25G

    DI: 08717872034713 · Model: 8525.406-00 · 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
    CUSTOM TDC VITREC.PACK VGP 25G
    Primary DI
    08717872034713
    Version / Model
    8525.406-00
    Catalog Number
    8525.406-00
    Company Name
    D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.
    Labeler DUNS
    407522184
    Distribution Status
    Not in Commercial Distribution
    Device Count in Pkg
    6
    Record Status
    Published
    Publish Date
    2024-09-27
    Public Version
    1
    Public Version Date
    2024-10-07
    Public Version Status
    New
    Public Device Record Key
    19367609-31ff-4d00-bc52-16c40dba6161
    Distribution End Date
    2024-09-27

    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
    Yes
    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 18717872034710
    Primary 08717872034713

    Premarket Submissions

    Submission Number Supplement Number
    K190875 000