BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Pro-Paks

    DI: 10810003224313 · Model: 221110B · MICROSPECIALITIES, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    10

    Basic Information

    Brand Name
    Pro-Paks
    Primary DI
    10810003224313
    Version / Model
    221110B
    Company Name
    MICROSPECIALITIES, INC.
    Labeler DUNS
    013469890
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    10
    Record Status
    Published
    Publish Date
    2022-12-11
    Public Version
    1
    Public Version Date
    2022-12-19
    Public Version Status
    New
    Public Device Record Key
    5811780a-da36-4e2c-bff8-4b22432a218e

    Device Description

    Ophthalmic pack. PRO-PAKS Personalized Eye Tray Systems offer the best option for Surgical Packs and a Systematized approach combined with the Personal Touch. PRO-PAKS personalized procedure trays offers a fully custom pack, from EXACT components to EXACT quantities and the ability to adapt the sequence of which the individual items are placed in the pack.

    Device Characteristics

    Single Use
    Yes
    Prescription Use (Rx)
    Yes
    Over the Counter (OTC)
    No
    Kit
    Yes
    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
    No
    Has Lot/Batch Number
    Yes
    Has Manufacturing Date
    Yes
    Has Expiration Date
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    Yes
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    OJK Eye Tray

    GMDN Terms

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

    Identifiers

    Type ID
    Primary 10810003224313
    Unit of Use 00810003224316