BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Tube set for suction (with 2 ports), single-use

    DI: 04056702008833 · Model: OTFLWTBING · W.O.M. World of Medicine GmbH
    View on AccessGUDID
    Product Codes
    2
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Tube set for suction (with 2 ports), single-use
    Primary DI
    04056702008833
    Version / Model
    OTFLWTBING
    Company Name
    W.O.M. World of Medicine GmbH
    Labeler DUNS
    316305242
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2020-11-01
    Public Version
    3
    Public Version Date
    2022-06-10
    Public Version Status
    Update
    Public Device Record Key
    81638c39-3fbc-4abd-9a5a-24cd778fba08

    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
    No
    Has Lot/Batch Number
    Yes
    Has Manufacturing Date
    Yes
    Has Expiration Date
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    Yes
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    HIG Insufflator, Hysteroscopic
    HET Laparoscope, Gynecologic (And Accessories)

    GMDN Terms

    Code Name
    60738 Endoscopic insufflation tubing set, single-use

    Identifiers

    Type ID
    Package 04056702008840
    Primary 04056702008833

    Premarket Submissions

    Submission Number Supplement Number
    K173489 000