BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Axium™

    DI: 05415067025616 · Model: MN13650 · SPINAL MODULATION, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Axium™
    Primary DI
    05415067025616
    Version / Model
    MN13650
    Catalog Number
    MN13650
    Company Name
    SPINAL MODULATION, INC.
    Labeler DUNS
    617312272
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-03-29
    Public Version
    3
    Public Version Date
    2018-07-06
    Public Version Status
    Update
    Public Device Record Key
    512cf466-55c3-467d-84bd-1bbafa0b5adc

    Device Description

    22cm Big Curve Delivery Sheath Kit

    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
    MR Unsafe
    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
    PMP Dorsal root ganglion stimulator for pain relief

    GMDN Terms

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

    Identifiers

    Type ID
    Primary 05415067025616

    Customer Contacts

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

    Premarket Submissions

    Submission Number Supplement Number
    P150004 000

    Device Sizes

    Type Value Unit Text
    Length 22 Centimeter

    Storage Conditions

    Type
    Handling Environment Humidity
    Temperature Range
    10 – 90 Percent (%) Relative Humidity
    Type
    Storage Environment Temperature
    Temperature Range
    14 – 122 Degrees Fahrenheit
    Type
    Storage Environment Temperature
    Temperature Range
    -10 – 50 Degrees Celsius
    Type
    Storage Environment Humidity
    Temperature Range
    10 – 90 Percent (%) Relative Humidity
    Type
    Handling Environment Temperature
    Temperature Range
    -10 – 50 Degrees Celsius
    Type
    Handling Environment Temperature
    Temperature Range
    14 – 122 Degrees Fahrenheit
    Type
    Special Storage Condition, Specify
    Special Conditions
    Keep dry. Do not use if package is damaged.