BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    INJEX®

    DI: 00643169986459 · Model: 97792 · MEDTRONIC, INC.
    View on AccessGUDID
    Product Codes
    2
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

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    Basic Information

    Brand Name
    INJEX®
    Primary DI
    00643169986459
    Version / Model
    97792
    Company Name
    MEDTRONIC, INC.
    Labeler DUNS
    006261481
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2018-04-29
    Public Version
    3
    Public Version Date
    2025-12-16
    Public Version Status
    Update
    Public Device Record Key
    db89e3f8-f8d7-4635-bbb5-eec99fea703c

    Device Description

    ACCY KIT 97792 INJEX BI-WING ANCHOR

    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
    LGW STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
    QRB Stimulator, spinal-cord, totally implanted for relief of pain due to diabetic neuropathy

    GMDN Terms

    Code Name
    44063 Neurosurgical procedure kit, non-medicated, single-use

    Identifiers

    Type ID
    Primary 00643169986459

    Customer Contacts

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

    Premarket Submissions

    Submission Number Supplement Number
    P840001 377

    Storage Conditions

    Type
    Storage Environment Temperature
    Temperature Range
    -30 – 135 Degrees Fahrenheit
    Type
    Storage Environment Temperature
    Temperature Range
    -34 – 57 Degrees Celsius