MN12050

GUDID 05415067027214

Lead Accessories Kit

ST. JUDE MEDICAL, INC.

Neurosurgical procedure kit, non-medicated, single-use

• Primary Device ID: 05415067027214
• NIH Device Record Key: 225962c9-7a26-4d09-86f7-fdaaeceabf26
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: DRG
• Catalog Number: MN12050
• Company DUNS: 149818952
• Company Name: ST. JUDE MEDICAL, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• 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

Operating and Storage Conditions

• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	05415067027214 [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: 4
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-07-21

Devices Manufactured by ST. JUDE MEDICAL, INC.

• 05414734504706 - Merlin@home™: 2024-11-12 Wireless Broadband Kit
• 05415067000989 - NA: 2024-10-09 AUX Out Cable
• 05415067006028 - NA: 2024-10-09 Adapter Cable
• 05415067049667 - EnSite™: 2024-09-09 X EP System Catheter Connector Cable
• 05415067049889 - Advisor™ HD Grid X, Sensor Enabled™: 2024-09-02 High Density Mapping Catheter
• 05415067050182 - Agilis™ NxT Steerable Introducer Dual-Reach™: 2024-08-23 Steerable Introducer
• 05415067049704 - EnSite™: 2024-08-22 X EP System Software Upgrade
• 05415067049711 - EnSite™: 2024-08-22 X EP System TactiFlex Ablation Catheter, Sensor Enabled Software Upgrade