BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    SJM™

    DI: 05415067019516 · Model: 1701 · ST. JUDE MEDICAL, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    SJM™
    Primary DI
    05415067019516
    Version / Model
    1701
    Catalog Number
    1701
    Company Name
    ST. JUDE MEDICAL, INC.
    Labeler DUNS
    149818952
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2015-03-12
    Public Version
    3
    Public Version Date
    2023-01-09
    Public Version Status
    Update
    Public Device Record Key
    d04ca154-a93d-4c62-bdf7-73da56ba4afb

    Device Characteristics

    Single Use
    Yes
    Prescription Use (Rx)
    Yes
    Over the Counter (OTC)
    No
    Kit
    Yes
    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
    Yes
    Has Expiration Date
    Yes
    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

    GMDN Terms

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

    Identifiers

    Type ID
    Primary 05415067019516

    Customer Contacts

    Phone
    +1(855)478-5833
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    P010032 000

    Storage Conditions

    Type
    Storage Environment Temperature
    Temperature Range
    14 – 131 Degrees Fahrenheit
    Type
    Storage Environment Humidity
    Temperature Range
    10 – 90 Percent (%) Relative Humidity
    Type
    Storage Environment Atmospheric Pressure
    Temperature Range
    70 – 150 KiloPascal
    Type
    Special Storage Condition, Specify
    Special Conditions
    DO NOT EXPOSE TO LIQUIDS OR EXCESSIVE MOISTURE
    Type
    Handling Environment Atmospheric Pressure
    Temperature Range
    70 – 150 KiloPascal
    Type
    Handling Environment Temperature
    Temperature Range
    14 – 131 Degrees Fahrenheit
    Type
    Handling Environment Humidity
    Temperature Range
    10 – 90 Percent (%) Relative Humidity
    Type
    Handling Environment Temperature
    Temperature Range
    -10 – 55 Degrees Celsius
    Type
    Storage Environment Temperature
    Temperature Range
    -10 – 55 Degrees Celsius