BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    EcoBalloon OBT RA

    DI: 04048223025475 · Model: 1285-96-11 · Pajunk GmbH Medizintechnologie
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    EcoBalloon OBT RA
    Primary DI
    04048223025475
    Version / Model
    1285-96-11
    Catalog Number
    1285-96-11
    Company Name
    Pajunk GmbH Medizintechnologie
    Labeler DUNS
    317654283
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2019-04-16
    Public Version
    2
    Public Version Date
    2021-03-16
    Public Version Status
    Update
    Public Device Record Key
    4cd72f14-9408-4dcc-acdd-d8206926bd8e
    Distribution End Date
    2025-03-15

    Device Description

    EcoBalloon OBT RA Blunt obturator for the insertion of ring-anchor balloons Ø 11mm

    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
    Yes
    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
    GCJ Laparoscope, general & plastic surgery

    GMDN Terms

    Code Name
    61424 Laparoscopic trocar blade, reusable

    Identifiers

    Type ID
    Primary 04048223025475

    Customer Contacts

    Phone
    +1(888)972-5865
    Email
    [email protected]