BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    N/A

    DI: 00763000994198 · Model: 3550-68 · MEDTRONIC, INC.
    View on AccessGUDID
    Product Codes
    7
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Let the assistant research this device

    The Research Assistant compiles product codes, classification, clearances and adverse events for this device — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Brand Name
    N/A
    Primary DI
    00763000994198
    Version / Model
    3550-68
    Company Name
    MEDTRONIC, INC.
    Labeler DUNS
    006261481
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2025-10-19
    Public Version
    2
    Public Version Date
    2026-01-07
    Public Version Status
    Update
    Public Device Record Key
    fc874fd7-8def-4c39-a95c-3e5dd01d9189

    Device Description

    ACCY KIT 3550-68 TWIST LOCK SCRN CBL MDR

    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
    MHY Stimulator, electrical, implanted, for parkinsonian tremor
    MBX Stimulator, thalamic, epilepsy, implanted
    OLM Deep brain stimulator for obsessive compulsive disorder (OCD)
    PJS Stimulator, electrical, implanted, for essential tremor
    NHL Stimulator, electrical, implanted, for parkinsonian symptoms
    MRU implanted subcortical electrical Stimulator (motor disorders)
    SGS Deep Brain Stimulation for the treatment of Dystonia

    GMDN Terms

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

    Identifiers

    Type ID
    Primary 00763000994198

    Customer Contacts

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

    Premarket Submissions

    Submission Number Supplement Number
    H020007 391
    H050003 342
    P960009 503