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    FDA UDI In Commercial Distribution 🇺🇸 United States

    Helveston Scleral Ruler

    DI: 08175700106719 · Model: AS2-101 · 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
    Helveston Scleral Ruler
    Primary DI
    08175700106719
    Version / Model
    AS2-101
    Catalog Number
    AS2-101
    Company Name
    AURORA SURGICAL, LLC
    Labeler DUNS
    968368832
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2022-11-14
    Public Version
    2
    Public Version Date
    2024-09-11
    Public Version Status
    Update
    Public Device Record Key
    c6282e21-a9e7-4fc1-b488-4afde0b398a3

    Device Description

    Helveston Scleral Ruler

    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
    HOE Caliper, Ophthalmic

    GMDN Terms

    Code Name
    44796 Medical ruler, reusable

    Identifiers

    Type ID
    Primary 08175700106719