BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    Symmetry Surgical

    DI: 00887482155615 · Model: GDH10 · ASPEN SURGICAL PRODUCTS, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Symmetry Surgical
    Primary DI
    00887482155615
    Version / Model
    GDH10
    Company Name
    ASPEN SURGICAL PRODUCTS, INC.
    Labeler DUNS
    027680821
    Distribution Status
    Not in Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2024-09-09
    Public Version
    3
    Public Version Date
    2025-10-29
    Public Version Status
    Update
    Public Device Record Key
    9d3a5fac-1a11-4d6f-b035-e4aeb1c12dc5
    Distribution End Date
    2024-09-10

    Device Description

    Secto® Handle, Angle Tip, 10 mm Reusable, Short, 8.5 cm Working Length

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    Yes
    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
    Yes
    PM Exempt
    No
    Has Serial Number
    No
    Has Lot/Batch Number
    Yes
    Has Manufacturing Date
    Yes
    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
    HET Laparoscope, Gynecologic (And Accessories)

    GMDN Terms

    Code Name
    63868 Laparoscopic surgery handle

    Identifiers

    Type ID
    Primary 00887482155615

    Premarket Submissions

    Submission Number Supplement Number
    K982428 000