BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    NA

    DI: 00643169073678 · Model: 21038 · MEDTRONIC PS MEDICAL, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    NA
    Primary DI
    00643169073678
    Version / Model
    21038
    Company Name
    MEDTRONIC PS MEDICAL, INC.
    Labeler DUNS
    089055867
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2015-07-10
    Public Version
    4
    Public Version Date
    2023-11-20
    Public Version Status
    Update
    Public Device Record Key
    4a3049a5-aa86-4bdc-bdad-ffee28c673f7

    Device Description

    GUIDEWIRE 21038 TEFLON COATED 100CM

    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
    JXG Shunt, central nervous system and components

    GMDN Terms

    Code Name
    46691 Gastro-urological guidewire, single-use

    Identifiers

    Type ID
    Primary 00643169073678

    Customer Contacts

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

    Premarket Submissions

    Submission Number Supplement Number
    K831396 000

    Device Sizes

    Type Value Unit Text
    Outer Diameter 0.46 Millimeter