S-2010

GUDID 15415067028652

Radiofrequency Cannula - Straight

ST. JUDE MEDICAL, INC.

Radio-frequency ablation system probe cannula, single-use

• Primary Device ID: 15415067028652
• NIH Device Record Key: 540edf81-4a68-4c65-8e96-a2355379cfb8
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: CLASSIC
• Catalog Number: S-2010
• 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

• Needle Gauge: 20 Gauge
• Length: 20 Centimeter
• Needle Gauge: 20 Gauge
• Length: 20 Centimeter
• Needle Gauge: 20 Gauge
• Length: 20 Centimeter
• Needle Gauge: 20 Gauge
• Length: 20 Centimeter
• Needle Gauge: 20 Gauge
• Length: 20 Centimeter
• Needle Gauge: 20 Gauge
• Length: 20 Centimeter
• Needle Gauge: 20 Gauge
• Length: 20 Centimeter
• Needle Gauge: 20 Gauge
• Length: 20 Centimeter
• Needle Gauge: 20 Gauge
• Length: 20 Centimeter
• Needle Gauge: 20 Gauge
• Length: 20 Centimeter
• Needle Gauge: 20 Gauge
• Length: 20 Centimeter
• Needle Gauge: 20 Gauge
• Length: 20 Centimeter
• Needle Gauge: 20 Gauge
• Length: 20 Centimeter
• Needle Gauge: 20 Gauge
• Length: 20 Centimeter
• Needle Gauge: 20 Gauge
• Length: 20 Centimeter
• Needle Gauge: 20 Gauge
• Length: 20 Centimeter
• Needle Gauge: 20 Gauge
• Length: 20 Centimeter
• Needle Gauge: 20 Gauge
• Length: 20 Centimeter
• Needle Gauge: 20 Gauge
• Length: 20 Centimeter
• Needle Gauge: 20 Gauge
• Length: 20 Centimeter
• Needle Gauge: 20 Gauge
• Length: 20 Centimeter
• Needle Gauge: 20 Gauge
• Length: 20 Centimeter
• Needle Gauge: 20 Gauge
• Length: 20 Centimeter
• Needle Gauge: 20 Gauge
• Length: 20 Centimeter
• Needle Gauge: 20 Gauge
• Length: 20 Centimeter
• Needle Gauge: 20 Gauge
• Length: 20 Centimeter
• Needle Gauge: 20 Gauge
• Length: 20 Centimeter
• Needle Gauge: 20 Gauge
• Length: 20 Centimeter
• Needle Gauge: 20 Gauge
• Length: 20 Centimeter
• Needle Gauge: 20 Gauge
• Length: 20 Centimeter
• Needle Gauge: 20 Gauge
• Length: 20 Centimeter
• Needle Gauge: 20 Gauge
• Length: 20 Centimeter
• Needle Gauge: 20 Gauge
• Length: 20 Centimeter
• Needle Gauge: 20 Gauge
• Length: 20 Centimeter
• Needle Gauge: 20 Gauge
• Length: 20 Centimeter
• Needle Gauge: 20 Gauge
• Length: 20 Centimeter

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	05415067028655 [Primary]
GS1	15415067028652 [Package]; Contains: 05415067028655; 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.

• 05415067053121 - EnSite™: 2025-04-11 X EP System Software Upgrade
• 05415067053138 - EnSite™: 2025-04-11 X EP System PFA Catheter Visualization Software License
• 05415067053145 - EnSite™: 2025-04-11 X EP System PFA Catheter Visualization Temporary Software License
• 05415067050045 - Neutrino™: 2025-02-19 NxT HF Cardiac Resynchronization Therapy Defibrillator VVED DDDRV
• 05415067050052 - Gallant™: 2025-02-19 HF Cardiac Resynchronization Therapy Defibrillator VVED DDDRV
• 05415067050076 - Neutrino™: 2025-02-19 NxT HF Cardiac Resynchronization Therapy Defibrillator VVED DDDRV
• 05415067050090 - Gallant™: 2025-02-19 HF Cardiac Resynchronization Therapy Defibrillator VVED DDDRV
• 05415067050106 - Entrant™: 2025-02-19 HF Cardiac Resynchronization Therapy Defibrillator VVED DDDRV