36700

GUDID 05415067051905

SCS Charging System

ADVANCED NEUROMODULATION SYSTEMS, INC.

Active implantable device control magnet

• Primary Device ID: 05415067051905
• NIH Device Record Key: d307eef6-8fd3-44dd-997b-b788110a8981
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 36700
• Catalog Number: 36700
• Company DUNS: 021675699
• Company Name: ADVANCED NEUROMODULATION SYSTEMS, 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: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• 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

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Excursions permitted from -10 - 55C. Store at room temperature 23C (73F)
• Special Storage Condition, Specify: Between 0 and 0 *Excursions permitted from -10 - 55C. Store at room temperature 23C (73F)
• Special Storage Condition, Specify: Between 0 and 0 *Excursions permitted from -10 - 55C. Store at room temperature 23C (73F)
• Special Storage Condition, Specify: Between 0 and 0 *Excursions permitted from -10 - 55C. Store at room temperature 23C (73F)
• Special Storage Condition, Specify: Between 0 and 0 *Excursions permitted from -10 - 55C. Store at room temperature 23C (73F)
• Special Storage Condition, Specify: Between 0 and 0 *Excursions permitted from -10 - 55C. Store at room temperature 23C (73F)
• Special Storage Condition, Specify: Between 0 and 0 *Excursions permitted from -10 - 55C. Store at room temperature 23C (73F)
• Special Storage Condition, Specify: Between 0 and 0 *Excursions permitted from -10 - 55C. Store at room temperature 23C (73F)
• Special Storage Condition, Specify: Between 0 and 0 *Excursions permitted from -10 - 55C. Store at room temperature 23C (73F)
• Special Storage Condition, Specify: Between 0 and 0 *Excursions permitted from -10 - 55C. Store at room temperature 23C (73F)
• Special Storage Condition, Specify: Between 0 and 0 *Excursions permitted from -10 - 55C. Store at room temperature 23C (73F)
• Special Storage Condition, Specify: Between 0 and 0 *Excursions permitted from -10 - 55C. Store at room temperature 23C (73F)
• Special Storage Condition, Specify: Between 0 and 0 *Excursions permitted from -10 - 55C. Store at room temperature 23C (73F)
• Special Storage Condition, Specify: Between 0 and 0 *Excursions permitted from -10 - 55C. Store at room temperature 23C (73F)
• Special Storage Condition, Specify: Between 0 and 0 *Excursions permitted from -10 - 55C. Store at room temperature 23C (73F)
• Special Storage Condition, Specify: Between 0 and 0 *Excursions permitted from -10 - 55C. Store at room temperature 23C (73F)

Device Identifiers

Device Issuing Agency	Device ID
GS1	05415067051905 [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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-02-03
• Device Publish Date: 2025-01-24

Devices Manufactured by ADVANCED NEUROMODULATION SYSTEMS, INC.

• 05415067051899 - NA: 2025-02-03 DBS Charging System
• 05415067051905 - NA: 2025-02-03SCS Charging System
• 05415067051905 - NA: 2025-02-03 SCS Charging System
• 05415067047663 - Liberta RC™: 2024-02-26 Implantable Pulse Generator
• 05415067047670 - NA: 2024-02-26 Charger Kit, Pectoral
• 05414734402477 - SJM™: 2020-02-06
• 05414734402613 - Eon Mini™: 2020-02-06 Charging System Charger
• 05414734402620 - Eon Mini™: 2020-02-06
• 05414734405300 - Eon Mini LE™: 2020-02-06