MN13650

GUDID 05415067053060

DRG Big Curve Delivery Sheath Kit

ADVANCED NEUROMODULATION SYSTEMS, INC.

Neurosurgical procedure kit, non-medicated, single-use

• Primary Device ID: 05415067053060
• NIH Device Record Key: 32010cf6-3282-4db4-92f3-d91ca627632e
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: MN13650
• Catalog Number: MN13650
• 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: true
• 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

Device Dimensions

• Length: 22 Centimeter
• Length: 22 Centimeter
• Length: 22 Centimeter
• Length: 22 Centimeter
• Length: 22 Centimeter
• Length: 22 Centimeter
• Length: 22 Centimeter
• Length: 22 Centimeter
• Length: 22 Centimeter
• Length: 22 Centimeter
• Length: 22 Centimeter
• Length: 22 Centimeter
• Length: 22 Centimeter

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature 23C/73F. Excursions allowed between -20C to 60C
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature 23C/73F. Excursions allowed between -20C to 60C
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature 23C/73F. Excursions allowed between -20C to 60C
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature 23C/73F. Excursions allowed between -20C to 60C
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature 23C/73F. Excursions allowed between -20C to 60C
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature 23C/73F. Excursions allowed between -20C to 60C
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature 23C/73F. Excursions allowed between -20C to 60C
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature 23C/73F. Excursions allowed between -20C to 60C
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature 23C/73F. Excursions allowed between -20C to 60C
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature 23C/73F. Excursions allowed between -20C to 60C
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature 23C/73F. Excursions allowed between -20C to 60C
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature 23C/73F. Excursions allowed between -20C to 60C
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature 23C/73F. Excursions allowed between -20C to 60C
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	05415067053060 [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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-12-15
• Device Publish Date: 2025-12-07

Devices Manufactured by ADVANCED NEUROMODULATION SYSTEMS, INC.

• 05415067053060 - NA: 2025-12-15DRG Big Curve Delivery Sheath Kit
• 05415067053060 - NA: 2025-12-15 DRG Big Curve Delivery Sheath Kit
• 05415067051882 - NA: 2025-04-17 External Pulse Generator, 2 Port Header
• 05415067051899 - NA: 2025-02-03 DBS 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