BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    KYPHON Xpander KyphoPak Tray

    DI: 00763000031763 · Model: KPT2002 · MEDTRONIC SOFAMOR DANEK, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    KYPHON Xpander KyphoPak Tray
    Primary DI
    00763000031763
    Version / Model
    KPT2002
    Company Name
    MEDTRONIC SOFAMOR DANEK, INC.
    Labeler DUNS
    830350380
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2019-01-26
    Public Version
    6
    Public Version Date
    2022-09-16
    Public Version Status
    Update
    Public Device Record Key
    5b3a92c2-3d83-4673-9a79-827c8e06219f

    Device Description

    KIT KPT2002 KYPHOPAK TRAY 20/3 FF W/OIS

    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
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    Yes
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    HRX Arthroscope

    GMDN Terms

    Code Name
    12143 Instrument tray, reusable

    Identifiers

    Type ID
    Primary 00763000031763

    Customer Contacts

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

    Premarket Submissions

    Submission Number Supplement Number
    K041454 000

    Storage Conditions

    Type
    Special Storage Condition, Specify
    Special Conditions
    Store in a cool, dry place