Eon™ 3851

GUDID 05414734402736

ADVANCED NEUROMODULATION SYSTEMS, INC.

Active-implantable-device communicator Multiple active implantable device programmer Multiple active implantable device programmer Multiple active implantable device programmer Multiple active implantable device programmer Multiple active implantable device programmer Multiple active implantable device programmer Multiple active implantable device programmer Multiple active implantable device programmer Multiple active implantable device programmer Multiple active implantable device programmer Multiple active implantable device programmer Multiple active implantable device programmer Multiple active implantable device programmer Multiple active implantable device programmer Multiple active implantable device programmer Multiple active implantable device programmer Multiple active implantable device programmer

• Primary Device ID: 05414734402736
• NIH Device Record Key: 66dd820b-7b55-4599-9f0e-dcebc1f328c8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Eon™
• Version Model Number: 3851
• Catalog Number: 3851
• Company DUNS: 021675699
• Company Name: ADVANCED NEUROMODULATION SYSTEMS, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: true
• 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

Operating and Storage Conditions

• Handling Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 150 KiloPascal
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 150 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 150 KiloPascal
• Handling Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 150 KiloPascal
• 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 55 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 150 KiloPascal
• Handling Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 150 KiloPascal
• 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 55 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 150 KiloPascal
• Handling Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 150 KiloPascal
• 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 55 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 150 KiloPascal
• Handling Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 150 KiloPascal
• 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 55 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 150 KiloPascal
• Handling Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 150 KiloPascal
• 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 55 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 150 KiloPascal
• Handling Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 150 KiloPascal
• 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 55 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 150 KiloPascal
• Handling Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 150 KiloPascal
• 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 55 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 150 KiloPascal
• Handling Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 150 KiloPascal
• 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 55 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 150 KiloPascal
• Handling Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 150 KiloPascal
• 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 55 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 150 KiloPascal
• Handling Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 150 KiloPascal
• 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 55 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 150 KiloPascal
• Handling Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 150 KiloPascal
• 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 55 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 150 KiloPascal
• Handling Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 150 KiloPascal
• 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 55 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 150 KiloPascal
• Handling Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 150 KiloPascal
• 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 55 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 150 KiloPascal
• Handling Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 150 KiloPascal
• 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 55 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 150 KiloPascal
• Handling Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 150 KiloPascal
• 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 55 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 150 KiloPascal
• Handling Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 150 KiloPascal
• 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 55 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 150 KiloPascal
• Handling Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 150 KiloPascal
• 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 55 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	05414734402736 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P010032

FDA Product Code

• LGW: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2014-10-22

On-Brand Devices [Eon™]

• 05414734402736: 3851
• 05414734402583: Rechargeable IPG, 16-Channel