BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    N/A

    DI: 00763000153304 · Model: 37500301 · MEDTRONIC, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    N/A
    Primary DI
    00763000153304
    Version / Model
    37500301
    Company Name
    MEDTRONIC, INC.
    Labeler DUNS
    796986144
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2019-07-12
    Public Version
    5
    Public Version Date
    2023-04-04
    Public Version Status
    Update
    Public Device Record Key
    8e426924-5d5b-438b-b69f-c015757238d7

    Device Description

    ACCY 37500301 PAIN ENS BOOT GLOBAL

    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
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    LGW STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF

    GMDN Terms

    Code Name
    31072 Personal device holder, single-use

    Identifiers

    Type ID
    Primary 00763000153304

    Customer Contacts

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

    Premarket Submissions

    Submission Number Supplement Number
    P840001 344

    Storage Conditions

    Type
    Storage Environment Temperature
    Temperature Range
    -31 – 135 Degrees Fahrenheit
    Type
    Storage Environment Temperature
    Temperature Range
    -35 – 57 Degrees Celsius