BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    AngioSculpt® PTCA Scoring Balloon Catheter

    DI: M370220030101 · Model: 2200-3010 · Angioscore Inc.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    AngioSculpt® PTCA Scoring Balloon Catheter
    Primary DI
    M370220030101
    Version / Model
    2200-3010
    Company Name
    Angioscore Inc.
    Labeler DUNS
    615286726
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2014-09-23
    Public Version
    3
    Public Version Date
    2019-10-07
    Public Version Status
    Update
    Public Device Record Key
    0b16a1a5-1733-468d-b4b6-3f5b5f5fd8d4

    Device Characteristics

    Single Use
    Yes
    Prescription Use (Rx)
    Yes
    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
    No
    Has Expiration Date
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    Yes
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    NWX Catheter, Percutaneous Transluminal Coronary Angioplasty (Ptca), Cutting/Scoring

    GMDN Terms

    Code Name
    47732 Coronary angioplasty balloon catheter, basic

    Identifiers

    Type ID
    Primary M370220030101