BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    USA Elite

    DI: 00821925002807 · Model: ETOR-24 · Gyrus Acmi, Inc.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    USA Elite
    Primary DI
    00821925002807
    Version / Model
    ETOR-24
    Company Name
    Gyrus Acmi, Inc.
    Labeler DUNS
    007198742
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-10-14
    Public Version
    4
    Public Version Date
    2023-08-14
    Public Version Status
    Update
    Public Device Record Key
    9c6503e8-1b7b-4841-89f4-f1629496db6f

    Device Description

    USA Elite System Continuous Flow Resectoscope Timberlake Obturator 24 Fr, (8 mm) Color Coded Yellow

    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
    No
    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
    HIH Hysteroscope (And Accessories)

    GMDN Terms

    Code Name
    35692 Rigid endoscope obturator

    Identifiers

    Type ID
    Primary 00821925002807

    Premarket Submissions

    Submission Number Supplement Number
    K890328 000