BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    ArcDuo, Guarded Depth Paired Ophthalmic Knife 9mm

    DI: 00844685014316 · Model: ARC-0002 · MICROSURGICAL TECHNOLOGY, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    ArcDuo, Guarded Depth Paired Ophthalmic Knife 9mm
    Primary DI
    00844685014316
    Version / Model
    ARC-0002
    Company Name
    MICROSURGICAL TECHNOLOGY, INC.
    Labeler DUNS
    097824130
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2025-10-10
    Public Version
    1
    Public Version Date
    2025-10-20
    Public Version Status
    New
    Public Device Record Key
    ba66efda-e233-4af8-ada3-114ba68a8944

    Device Description

    The ArcDUO device is a single-use, sterile ophthalmic knife that is intended to make controlled depth paired arcuate incisions on the cornea at or near the limbus.

    Device Characteristics

    Single Use
    Yes
    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
    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
    HNN Knife, Ophthalmic

    GMDN Terms

    Code Name
    46741 Ophthalmic knife, single-use

    Identifiers

    Type ID
    Primary 00844685014316