7210752

GUDID 03596010563279

TFCC MENDER DISPOSABLE SUTURE SYSTEM

Smith & Nephew, Inc.

Arthroscopic surgical procedure kit, non-medicated, single-use

• Primary Device ID: 03596010563279
• NIH Device Record Key: 40ab7101-0b77-47c1-9d90-c3609fa10737
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 7210752
• Catalog Number: 7210752
• 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: true
• 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	03596010563279 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K885311

FDA Product Code

• HWQ: PASSER

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

Devices Manufactured by Smith & Nephew, Inc.

• 00885556905470 - NA: 2025-03-12 VARIABLE ANGLE VALGUS GUIDE
• 00885556880876 - EVOS: 2025-02-28 EVOS 2.7MM STAGGERED PATELLA PLATE
• 00885556880883 - EVOS: 2025-02-28 EVOS 2.7MM SPLIT PATELLA PLATE
• 00885556886403 - EVOS: 2025-02-28 EVOS 2.7MM MESH PATELLA PLATE - SMALL
• 00885556886410 - EVOS: 2025-02-28 EVOS 2.7MM MESH PATELLA PLATE - LARGE
• 23596010587682 - FOOTPRINT: 2025-01-10 REPLACEMENT END CAPS FOR MALLET SET OF 2
• 00885556905463 - NA: 2024-12-25 INSERT TRIAL PITCHFORK
• 00885556915288 - NA: 2024-12-25 LM/RL TIBIA ALIGNMENT GUIDE SHORT