DYONICS RF, DYNAMO 72202149

GUDID 03596010624949

DYONICS RF GENERATOR

Smith & Nephew, Inc.

Arthroscopic irrigation/insufflation system Arthroscopic irrigation/insufflation system Arthroscopic irrigation/insufflation system Arthroscopic irrigation/insufflation system Arthroscopic irrigation/insufflation system Arthroscopic irrigation/insufflation system Arthroscopic irrigation/insufflation system Arthroscopic irrigation/insufflation system Arthroscopic irrigation/insufflation system Arthroscopic irrigation/insufflation system Arthroscopic irrigation/insufflation system Arthroscopic irrigation/insufflation system Arthroscopic irrigation/insufflation system Arthroscopic irrigation/insufflation system

• Primary Device ID: 03596010624949
• NIH Device Record Key: 34ac3c2c-c883-45ab-80ee-baa56409bd2e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DYONICS RF, DYNAMO
• Version Model Number: 72202149
• Catalog Number: 72202149
• 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: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	03596010624949 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K090393

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: 4
• Public Version Date: 2020-01-31
• Device Publish Date: 2015-08-29

On-Brand Devices [DYONICS RF, DYNAMO]

• 03596010624949: DYONICS RF GENERATOR
• 03596010625137: DYONICS RF-S DYNAMO 90 DEG