BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Male Remeex System

    DI: 08437007606034 · Model: MRS · DESARROLLO E INVESTIGACION MEDICA ARAGONESA SL
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Male Remeex System
    Primary DI
    08437007606034
    Version / Model
    MRS
    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
    2
    Public Version Date
    2022-06-10
    Public Version Status
    Update
    Public Device Record Key
    76a9028f-0860-409c-8f38-1e96ffb5eb96

    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
    No
    Has Serial Number
    Yes
    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
    OTM Mesh, Surgical, For Stress Urinary Incontinence, Male

    GMDN Terms

    Code Name
    35280 Urethral sphincter prosthesis, non-powered

    Identifiers

    Type ID
    Primary 08437007606034