BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Osto System

    DI: 07500463968334 · Model: Adult · Solomed, S.A. de C.V.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    4

    Basic Information

    Brand Name
    Osto System
    Primary DI
    07500463968334
    Version / Model
    Adult
    Company Name
    Solomed, S.A. de C.V.
    Labeler DUNS
    588625921
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    4
    Record Status
    Published
    Publish Date
    2019-05-30
    Public Version
    2
    Public Version Date
    2019-12-11
    Public Version Status
    Update
    Public Device Record Key
    acd1ebcb-23aa-42eb-b85e-4fc865e8ae17

    Device Description

    Equipment for colostomy or ileostomy

    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
    Yes
    Has Expiration Date
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    FON Bag, Drainage, With Adhesive, Ostomy

    GMDN Terms

    Code Name
    31075 One-piece intestinal ostomy bag, open-ended

    Identifiers

    Type ID
    Primary 07500463968334
    Unit of Use 17500463968331