Axium™ MN10450-90A

GUDID 05415067025548

90cm SlimTip™ Implant Lead Kit

SPINAL MODULATION, INC.

Analgesic spinal cord electrical stimulation system

• Primary Device ID: 05415067025548
• NIH Device Record Key: 49126fe8-5825-4e18-87e9-3be6c218a8da
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Axium™
• Version Model Number: MN10450-90A
• Catalog Number: MN10450-90A
• Company DUNS: 617312272
• Company Name: SPINAL MODULATION, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com

Device Dimensions

• Length: 90 Centimeter
• Length: 90 Centimeter
• Length: 90 Centimeter
• Length: 90 Centimeter
• Length: 90 Centimeter
• Length: 90 Centimeter
• Length: 90 Centimeter
• Length: 90 Centimeter
• Length: 90 Centimeter
• Length: 90 Centimeter
• Length: 90 Centimeter
• Length: 90 Centimeter
• Length: 90 Centimeter
• Length: 90 Centimeter
• Length: 90 Centimeter
• Length: 90 Centimeter
• Length: 90 Centimeter
• Length: 90 Centimeter

Operating and Storage Conditions

• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 14 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry. Do not use if package is damaged.
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry. Do not use if package is damaged.
• Handling Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 14 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry. Do not use if package is damaged.
• Handling Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 14 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry. Do not use if package is damaged.
• Handling Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 14 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry. Do not use if package is damaged.
• Handling Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 14 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry. Do not use if package is damaged.
• Handling Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 14 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry. Do not use if package is damaged.
• Handling Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 14 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry. Do not use if package is damaged.
• Handling Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 14 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry. Do not use if package is damaged.
• Handling Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 14 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry. Do not use if package is damaged.
• Handling Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 14 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry. Do not use if package is damaged.
• Handling Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 14 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry. Do not use if package is damaged.
• Handling Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 14 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry. Do not use if package is damaged.
• Handling Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 14 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry. Do not use if package is damaged.
• Handling Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 14 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry. Do not use if package is damaged.
• Handling Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 14 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry. Do not use if package is damaged.
• Handling Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 14 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry. Do not use if package is damaged.
• Handling Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 14 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry. Do not use if package is damaged.
• Handling Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 14 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	05415067025548 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P150004

FDA Product Code

• PMP: Dorsal root ganglion stimulator for pain relief

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-03-29

On-Brand Devices [Axium™]

• 05415067027344: Lead Accessories Kit
• 05415067027337: 50cm SlimTip™ Implant Lead Kit
• 05415067025708: Curved Needle
• 05415067025678: Lead Accessories Kit
• 05415067025616: 22cm Big Curve Delivery Sheath Kit
• 05415067025609: 22cm Small Curve Delivery Sheath Kit
• 05415067025562: 50cm Lead Extension Kit
• 05415067025555: Connector Cable Kit
• 05415067025548: 90cm SlimTip™ Implant Lead Kit
• 05415067025531: 50cm SlimTip™ Implant Lead Kit
• 05415067025524: 90cm SlimTip™ Trial Lead Kit
• 05415067025517: 50cm SlimTip™ Trial Lead Kit