BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Remeex System - Passer Handle

    DI: 08437007606836 · Model: AR-05 · DESARROLLO E INVESTIGACION MEDICA ARAGONESA SL
    View on AccessGUDID
    Product Codes
    2
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Remeex System - Passer Handle
    Primary DI
    08437007606836
    Version / Model
    AR-05
    Company Name
    DESARROLLO E INVESTIGACION MEDICA ARAGONESA SL
    Labeler DUNS
    513271056
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2020-10-19
    Public Version
    1
    Public Version Date
    2020-10-27
    Public Version Status
    New
    Public Device Record Key
    8a4c6d79-37d2-4c13-be70-3b129a6b9c7b

    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
    No
    Has Serial Number
    Yes
    Has Lot/Batch Number
    Yes
    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
    OTN Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator
    OTM Mesh, Surgical, For Stress Urinary Incontinence, Male

    GMDN Terms

    Code Name
    47829 Surgical instrument handle, non-torque-limiting

    Identifiers

    Type ID
    Primary 08437007606836