S-1510

GUDID 15415067028461

Radiofrequency Cannula - Straight

ST. JUDE MEDICAL, INC.

Radio-frequency ablation system probe cannula, single-use

• Primary Device ID: 15415067028461
• NIH Device Record Key: e4f30ba0-6fc6-4e94-8b82-227f6a183a85
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: CLASSIC
• Catalog Number: S-1510
• Company DUNS: 149818952
• Company Name: ST. JUDE MEDICAL, 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: 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
• 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: 15 Centimeter
• Needle Gauge: 20 Gauge
• Length: 15 Centimeter
• Needle Gauge: 20 Gauge
• Length: 15 Centimeter
• Needle Gauge: 20 Gauge
• Length: 15 Centimeter
• Needle Gauge: 20 Gauge
• Length: 15 Centimeter
• Needle Gauge: 20 Gauge
• Length: 15 Centimeter
• Needle Gauge: 20 Gauge
• Length: 15 Centimeter
• Needle Gauge: 20 Gauge
• Length: 15 Centimeter
• Needle Gauge: 20 Gauge
• Length: 15 Centimeter
• Needle Gauge: 20 Gauge
• Length: 15 Centimeter
• Needle Gauge: 20 Gauge
• Length: 15 Centimeter
• Needle Gauge: 20 Gauge
• Length: 15 Centimeter
• Needle Gauge: 20 Gauge
• Length: 15 Centimeter
• Needle Gauge: 20 Gauge
• Length: 15 Centimeter
• Needle Gauge: 20 Gauge
• Length: 15 Centimeter
• Needle Gauge: 20 Gauge
• Length: 15 Centimeter
• Needle Gauge: 20 Gauge
• Length: 15 Centimeter
• Needle Gauge: 20 Gauge
• Length: 15 Centimeter
• Needle Gauge: 20 Gauge
• Length: 15 Centimeter
• Needle Gauge: 20 Gauge
• Length: 15 Centimeter
• Needle Gauge: 20 Gauge
• Length: 15 Centimeter
• Needle Gauge: 20 Gauge
• Length: 15 Centimeter
• Needle Gauge: 20 Gauge
• Length: 15 Centimeter
• Needle Gauge: 20 Gauge
• Length: 15 Centimeter
• Needle Gauge: 20 Gauge
• Length: 15 Centimeter
• Needle Gauge: 20 Gauge
• Length: 15 Centimeter
• Needle Gauge: 20 Gauge
• Length: 15 Centimeter
• Needle Gauge: 20 Gauge
• Length: 15 Centimeter
• Needle Gauge: 20 Gauge
• Length: 15 Centimeter
• Needle Gauge: 20 Gauge
• Length: 15 Centimeter
• Needle Gauge: 20 Gauge
• Length: 15 Centimeter
• Needle Gauge: 20 Gauge
• Length: 15 Centimeter
• Needle Gauge: 20 Gauge
• Length: 15 Centimeter
• Needle Gauge: 20 Gauge
• Length: 15 Centimeter
• Needle Gauge: 20 Gauge
• Length: 15 Centimeter
• Needle Gauge: 20 Gauge
• Length: 15 Centimeter
• Needle Gauge: 20 Gauge

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool and dry place; avoid exposure to extreme temperatures
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool and dry place; avoid exposure to extreme temperatures
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool and dry place; avoid exposure to extreme temperatures
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool and dry place; avoid exposure to extreme temperatures
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool and dry place; avoid exposure to extreme temperatures
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool and dry place; avoid exposure to extreme temperatures
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool and dry place; avoid exposure to extreme temperatures
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool and dry place; avoid exposure to extreme temperatures
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool and dry place; avoid exposure to extreme temperatures
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool and dry place; avoid exposure to extreme temperatures
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool and dry place; avoid exposure to extreme temperatures
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool and dry place; avoid exposure to extreme temperatures
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool and dry place; avoid exposure to extreme temperatures
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool and dry place; avoid exposure to extreme temperatures
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool and dry place; avoid exposure to extreme temperatures
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool and dry place; avoid exposure to extreme temperatures
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool and dry place; avoid exposure to extreme temperatures
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool and dry place; avoid exposure to extreme temperatures
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool and dry place; avoid exposure to extreme temperatures
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool and dry place; avoid exposure to extreme temperatures
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool and dry place; avoid exposure to extreme temperatures
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool and dry place; avoid exposure to extreme temperatures
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool and dry place; avoid exposure to extreme temperatures
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool and dry place; avoid exposure to extreme temperatures
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool and dry place; avoid exposure to extreme temperatures
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool and dry place; avoid exposure to extreme temperatures
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool and dry place; avoid exposure to extreme temperatures
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool and dry place; avoid exposure to extreme temperatures
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool and dry place; avoid exposure to extreme temperatures
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool and dry place; avoid exposure to extreme temperatures
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool and dry place; avoid exposure to extreme temperatures
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool and dry place; avoid exposure to extreme temperatures
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool and dry place; avoid exposure to extreme temperatures
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool and dry place; avoid exposure to extreme temperatures
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool and dry place; avoid exposure to extreme temperatures
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool and dry place; avoid exposure to extreme temperatures

Device Identifiers

Device Issuing Agency	Device ID
GS1	05415067028464 [Primary]
GS1	15415067028461 [Package]; Contains: 05415067028464; Package: [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K090955

FDA Product Code

• GXI: PROBE, RADIOFREQUENCY LESION

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2017-04-10

Devices Manufactured by ST. JUDE MEDICAL, INC.

• 05415067034809 - Merlin@home™: 2024-11-21 Transmitter
• 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