BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Ophthalmic Speculum

    DI: 08175700102001 · Model: AS1-120S · AURORA SURGICAL, LLC
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

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    Basic Information

    Brand Name
    Ophthalmic Speculum
    Primary DI
    08175700102001
    Version / Model
    AS1-120S
    Catalog Number
    AS1-120S
    Company Name
    AURORA SURGICAL, LLC
    Labeler DUNS
    968368832
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2022-11-11
    Public Version
    1
    Public Version Date
    2022-11-21
    Public Version Status
    New
    Public Device Record Key
    ba1d715a-ae7b-4b3a-ac54-9cf51729b84b

    Device Description

    Kershner Reversible Solid Blade Speculum, Stainless Steel

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    No
    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
    Yes
    Has Serial Number
    No
    Has Lot/Batch Number
    No
    Has Manufacturing Date
    No
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    Yes
    Sterilization Methods
    Moist Heat or Steam Sterilization

    Product Codes

    Code Name
    HNC Specula, Ophthalmic

    GMDN Terms

    Code Name
    35349 Eyelid speculum, reusable

    Identifiers

    Type ID
    Primary 08175700102001