ABLATOR 7209657

GUDID 03596010470355

ABLATOR VULCAN 60 DEG

Smith & Nephew, Inc.

Arthroscopic probe

• Primary Device ID: 03596010470355
• NIH Device Record Key: 7a2256fc-7a57-4fbf-8fcd-9d6d17890a52
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ABLATOR
• Version Model Number: 7209657
• Catalog Number: 7209657
• 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: true
• Lot Batch: true
• Serial Number: false
• 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(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	03596010470355 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K003893

FDA Product Code

• HRX: ARTHROSCOPE

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2020-01-31
• Device Publish Date: 2015-08-30

On-Brand Devices [ABLATOR]

• 03596010470423: CHISEL VULCAN STRAIGHT W/INTEGRATED CBL
• 03596010470393: ABLATOR-S VULCAN 60 DEG
• 03596010470355: ABLATOR VULCAN 60 DEG
• 03596010470584: ABLATOR-S MICRO VULCAN 2MM 60 DEG
• 03596010470577: ABLATOR VULCAN 60 DEG 2.0MM
• 03596010470416: ABLATOR-S VULCAN 90 DEG HP
• 03596010470409: ABLATOR-S 2MM 60DEG
• 03596010470386: ABLATOR-S VULCAN 90 DEG
• 03596010470379: ABLATOR VULCAN 90 DEG HP
• 03596010470362: ABLATOR MICRO VULCAN INTEGRATED
• 03596010470348: PROBE ABLATOR 30 DEG
• 03596010470331: VULCAN ABLATOR 90 DEG INTEGRATED