VULCAN 72201356

GUDID 03596010612793

PCMCIA CARD SOFTWARE VERSION 3.71 VULC

Smith & Nephew, Inc.

Radio-frequency ablation system

• Primary Device ID: 03596010612793
• NIH Device Record Key: effc39d0-4b26-4707-913b-0d2925d023ec
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VULCAN
• Version Model Number: 72201356
• Catalog Number: 72201356
• Company DUNS: 109903521
• Company Name: Smith & Nephew, 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: false
• Lot Batch: false
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• 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(800)821-5700
• Email: gudid@smith-nephew.com
• Phone: +1(800)821-5700
• Email: gudid@smith-nephew.com
• Phone: +1(800)821-5700
• Email: gudid@smith-nephew.com
• Phone: +1(800)821-5700
• Email: gudid@smith-nephew.com
• Phone: +1(800)821-5700
• Email: gudid@smith-nephew.com
• Phone: +1(800)821-5700
• Email: gudid@smith-nephew.com
• Phone: +1(800)821-5700
• Email: gudid@smith-nephew.com
• Phone: +1(800)821-5700
• Email: gudid@smith-nephew.com
• Phone: +1(800)821-5700
• Email: gudid@smith-nephew.com
• Phone: +1(800)821-5700
• Email: gudid@smith-nephew.com
• Phone: +1(800)821-5700
• Email: gudid@smith-nephew.com
• Phone: +1(800)821-5700
• Email: gudid@smith-nephew.com
• Phone: +1(800)821-5700
• Email: gudid@smith-nephew.com
• Phone: +1(800)821-5700
• Email: gudid@smith-nephew.com
• Phone: +1(800)821-5700
• Email: gudid@smith-nephew.com
• Phone: +1(800)821-5700
• Email: gudid@smith-nephew.com
• Phone: +1(800)821-5700
• Email: gudid@smith-nephew.com
• Phone: +1(800)821-5700
• Email: gudid@smith-nephew.com
• Phone: +1(800)821-5700
• Email: gudid@smith-nephew.com
• Phone: +1(800)821-5700
• Email: gudid@smith-nephew.com
• Phone: +1(800)821-5700
• Email: gudid@smith-nephew.com
• Phone: +1(800)821-5700
• Email: gudid@smith-nephew.com
• Phone: +1(800)821-5700
• Email: gudid@smith-nephew.com
• Phone: +1(800)821-5700
• Email: gudid@smith-nephew.com
• Phone: +1(800)821-5700
• Email: gudid@smith-nephew.com
• Phone: +1(800)821-5700
• Email: gudid@smith-nephew.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	03596010612793 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K991140

FDA Product Code

• GEI: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2020-01-31
• Device Publish Date: 2015-08-29

On-Brand Devices [VULCAN]

• 00885556603321: KIT VULCAN GEN ITALY
• 00885556586358: RFB VULCAN GENERATOR
• 00885556586341: SVCE REPL VULCAN GENERATOR
• 00885556539651: MTO KIT VULCAN GEN AUSTRALIA
• 00885554031225: SERVICE REPLACEMENT VULCAN GENERATOR
• 00885554013160: KIT VULCAN DOMESTIC
• 00885554012996: KIT AUSTRALIA
• 00885554012378: KIT VULCAN GEN U.K.
• 00885554011951: KIT ITALY
• 00885554011890: KIT VULCAN GEN DOMESTIC
• 00885554010770: MTO KIT VULCAN GEN S. AFRICA /
• 03596010612793: PCMCIA CARD SOFTWARE VERSION 3.71 VULC
• 03596010554024: PCMCIA CARD VER 3.70 VULCAN GEN
• 03596010534408: MTO PCMCIA CARD V3.51S1 VULCAN GEN
• 03596010519399: VULCAN GENERATOR CE MARK
• 03596010480521: KIT VULCAN GEN CONTL EUROPE
• 03596010613561: VULCAN GENERATOR ONLY REFURBISHED CE MARK
• 03596010542182: VULCAN GENERATOR ONLY SERVICE REPLACEMENT
• 03596010470546: FOOTSWITCH VULCAN