BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    INDURA ® 1P

    DI: 00643169158092 · Model: 8709SC · MEDTRONIC, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    INDURA ® 1P
    Primary DI
    00643169158092
    Version / Model
    8709SC
    Company Name
    MEDTRONIC, INC.
    Labeler DUNS
    796986144
    Distribution Status
    Not in Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-04-27
    Public Version
    3
    Public Version Date
    2018-07-06
    Public Version Status
    Update
    Public Device Record Key
    96ad4d58-904a-4bfb-823c-a89005a2bde7
    Distribution End Date
    2017-03-06

    Device Description

    CATH 8709SC SUTERLESS CONN UPDATE JUNCOS

    Device Characteristics

    Single Use
    Yes
    Prescription Use (Rx)
    Yes
    Over the Counter (OTC)
    No
    Kit
    No
    Combination Product
    Yes
    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
    Yes
    Has Lot/Batch Number
    No
    Has Manufacturing Date
    No
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    Yes
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    LKK PUMP, INFUSION, IMPLANTED, PROGRAMMABLE

    GMDN Terms

    Code Name
    35687 General-purpose implantable infusion pump, programmable

    Identifiers

    Type ID
    Primary 00643169158092

    Customer Contacts

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

    Premarket Submissions

    Submission Number Supplement Number
    P860004 167