BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Orbit Subretinal Delivery System

    DI: 00850009362001 · Model: PN1008904-001 · Gyroscope Usa, Inc.
    View on AccessGUDID
    Product Codes
    0
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

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    Basic Information

    Brand Name
    Orbit Subretinal Delivery System
    Primary DI
    00850009362001
    Version / Model
    PN1008904-001
    Company Name
    Gyroscope Usa, Inc.
    Labeler DUNS
    071418804
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2020-09-29
    Public Version
    1
    Public Version Date
    2020-10-07
    Public Version Status
    New
    Public Device Record Key
    fc039dfb-9f73-4328-9e3c-09265a98222b

    Device Description

    Subretinal Injection Device Set

    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
    No
    Has Serial Number
    Yes
    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

    GMDN Terms

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

    Identifiers

    Type ID
    Primary 00850009362001