72203418

GUDID 03596010657589

DIGITAL TO ANALOG CONVERTER BOX

Smith & Nephew, Inc.

Endoscopic video imaging system Endoscopic video imaging system Endoscopic video imaging system Endoscopic video imaging system Endoscopic video imaging system Endoscopic video imaging system Endoscopic video imaging system Endoscopic video imaging system Endoscopic video imaging system Endoscopic video imaging system Endoscopic video imaging system Endoscopic video imaging system Endoscopic video imaging system Endoscopic video imaging system

• Primary Device ID: 03596010657589
• NIH Device Record Key: 2da96239-22b3-469d-b88a-36bcc5ec2dc6
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 72203418
• Catalog Number: 72203418
• 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	03596010657589 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K014158

FDA Product Code

• GCJ: Laparoscope, general & plastic surgery

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

Devices Manufactured by Smith & Nephew, Inc.

• 00885556817667 - TULA: 2024-05-07 TULA KIT- UNILATERAL (NST007068)
• 00885556890745 - Q-FIX: 2024-05-06 Q-FIX ULTRA
• 00885556890752 - ULTRABRACE: 2024-05-06 ULTRABRACE KIT
• 00885556890769 - FOOTPRINT: 2024-05-06 FOOTPRINT MINI PK 3.5MM
• 00885556890790 - Q-FIX: 2024-05-06 2.9MM CANNULATED DRILL FOR Q-FIX ULTRA & 1.25MM DRILL PIN
• 00885556890912 - FOOTPRINT: 2024-05-06 FOOTPRINT MINI DRILL 3.5MM
• 00885556901335 - FOOTPRINT: 2024-05-06 FOOTPRINT MINI DRILL 3.7MM
• 20885556817692 - TULA: 2024-05-06 TULA EARPLUG 10-PACK- SIZE 2 (NST007071)