BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    NA

    DI: 00643169887435 · Model: 3550-03 · MEDTRONIC, INC.
    View on AccessGUDID
    Product Codes
    7
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

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    Basic Information

    Brand Name
    NA
    Primary DI
    00643169887435
    Version / Model
    3550-03
    Company Name
    MEDTRONIC, INC.
    Labeler DUNS
    796986144
    Distribution Status
    Not in Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2017-10-08
    Public Version
    4
    Public Version Date
    2023-07-12
    Public Version Status
    Update
    Public Device Record Key
    0533f68e-c572-4716-b5d5-d0b78c7d611c
    Distribution End Date
    2023-05-24

    Device Description

    ACCY KIT 3550-03 DBS TWSTLCK SCRNCBL FWU

    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
    NHL STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN SYMPTOMS
    LGW STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
    MHY STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
    EZW Stimulator, electrical, implantable, for incontinence
    GZB STIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF)
    PJS Stimulator, electrical, implanted, for essential tremor
    QON Implanted electrical device intended for treatment of fecal incontinence

    GMDN Terms

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

    Identifiers

    Type ID
    Primary 00643169887435

    Customer Contacts

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

    Premarket Submissions

    Submission Number Supplement Number
    P840001 231
    P960009 287
    P970004 250