DYONICS RF 72202149S

GUDID 03596010648112

SVCE REPL 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

• Primary Device ID: 03596010648112
• NIH Device Record Key: 3658ad20-edfe-432c-a8e3-cf905f48f857
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DYONICS RF
• Version Model Number: 72202149S
• Catalog Number: 72202149S
• Company DUNS: 045483575
• 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)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM

Device Identifiers

Device Issuing Agency	Device ID
GS1	03596010648112 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K093165

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: 2023-09-07
• Device Publish Date: 2015-09-21

On-Brand Devices [DYONICS RF]

• 00885554017298: KIT PWR CORD INTL DYONICS RF GEN
• 00885554016888: KIT PWR CORD US DYONICS RF GEN
• 03596010625038: FOOT PEDAL DYONICS RF GENERATOR
• 03596010648112: SVCE REPL DYONICS RF GENERATOR
• 03596010625144: DYONICS RF CONTRACT 30 DEG