013644

GUDID 03596010091499

INTRODUCER REAR ENTRY

Smith & Nephew, Inc.

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• Primary Device ID: 03596010091499
• NIH Device Record Key: de420a42-0e6f-4909-b86e-152e4c22a375
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 013644
• Catalog Number: 013644
• 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: true
• Serial Number: false
• 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)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
• 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
• 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	03596010091499 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K832277

FDA Product Code

• HRX: ARTHROSCOPE

Sterilization

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

[03596010091499]

Moist Heat or Steam Sterilization

[03596010091499]

Moist Heat or Steam Sterilization

[03596010091499]

Moist Heat or Steam Sterilization

[03596010091499]

Moist Heat or Steam Sterilization

[03596010091499]

Moist Heat or Steam Sterilization

[03596010091499]

Moist Heat or Steam Sterilization

[03596010091499]

Moist Heat or Steam Sterilization

[03596010091499]

Moist Heat or Steam Sterilization

[03596010091499]

Moist Heat or Steam Sterilization

[03596010091499]

Moist Heat or Steam Sterilization

[03596010091499]

Moist Heat or Steam Sterilization

[03596010091499]

Moist Heat or Steam Sterilization

[03596010091499]

Moist Heat or Steam Sterilization

[03596010091499]

Moist Heat or Steam Sterilization

[03596010091499]

Moist Heat or Steam Sterilization

[03596010091499]

Moist Heat or Steam Sterilization

[03596010091499]

Moist Heat or Steam Sterilization

[03596010091499]

Moist Heat or Steam Sterilization

[03596010091499]

Moist Heat or Steam Sterilization

[03596010091499]

Moist Heat or Steam Sterilization

[03596010091499]

Moist Heat or Steam Sterilization

[03596010091499]

Moist Heat or Steam Sterilization

[03596010091499]

Moist Heat or Steam Sterilization

[03596010091499]

Moist Heat or Steam Sterilization

[03596010091499]

Moist Heat or Steam Sterilization

[03596010091499]

Moist Heat or Steam Sterilization

[03596010091499]

Moist Heat or Steam Sterilization

[03596010091499]

Moist Heat or Steam Sterilization

[03596010091499]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2020-01-31
• Device Publish Date: 2015-08-30

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)