BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    KYPHON® Inflation Syringe

    DI: 00613994686374 · Model: A08A · MEDTRONIC SOFAMOR DANEK, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    KYPHON® Inflation Syringe
    Primary DI
    00613994686374
    Version / Model
    A08A
    Company Name
    MEDTRONIC SOFAMOR DANEK, INC.
    Labeler DUNS
    830350380
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-07-16
    Public Version
    5
    Public Version Date
    2020-05-06
    Public Version Status
    Update
    Public Device Record Key
    7172c6b6-77b1-49cb-b50b-8ce395eed4f4

    Device Description

    SYRINGE A08A KYPHX XPANDER INFLATION

    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
    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
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    Yes
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    DXT INJECTOR AND SYRINGE, ANGIOGRAPHIC

    GMDN Terms

    Code Name
    17541 Catheter/overtube balloon inflator, single-use

    Identifiers

    Type ID
    Primary 00613994686374

    Customer Contacts

    Phone
    +1(800)633-8766
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K011811 000