013642D

GUDID 00885556558768

REFURBREAR ENTRY AIMER-RIGHT

Smith & Nephew, Inc.

Orthopaedic implant aiming arm Orthopaedic implant aiming arm Orthopaedic implant aiming arm Orthopaedic implant aiming arm Orthopaedic implant aiming arm Orthopaedic implant aiming arm Orthopaedic implant aiming arm Orthopaedic implant aiming arm Orthopaedic implant aiming arm Orthopaedic implant aiming arm Orthopaedic implant aiming arm Orthopaedic implant aiming arm Orthopaedic implant aiming arm Orthopaedic implant aiming arm Orthopaedic implant aiming arm Orthopaedic implant aiming arm Orthopaedic implant aiming arm Orthopaedic implant aiming arm Orthopaedic implant aiming arm Orthopaedic implant aiming arm Orthopaedic implant aiming arm Orthopaedic implant aiming arm Orthopaedic implant aiming arm Orthopaedic implant aiming arm Orthopaedic implant aiming arm Orthopaedic implant aiming arm Orthopaedic implant aiming arm Orthopaedic implant aiming arm Orthopaedic implant aiming arm Orthopaedic implant aiming arm Orthopaedic implant aiming arm

• Primary Device ID: 00885556558768
• NIH Device Record Key: c8403f0a-f348-493b-b481-48c7a9cfdf12
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 013642D
• Catalog Number: 013642D
• 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)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
• 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	00885556558768 [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

[00885556558768]

Moist Heat or Steam Sterilization

[00885556558768]

Moist Heat or Steam Sterilization

[00885556558768]

Moist Heat or Steam Sterilization

[00885556558768]

Moist Heat or Steam Sterilization

[00885556558768]

Moist Heat or Steam Sterilization

[00885556558768]

Moist Heat or Steam Sterilization

[00885556558768]

Moist Heat or Steam Sterilization

[00885556558768]

Moist Heat or Steam Sterilization

[00885556558768]

Moist Heat or Steam Sterilization

[00885556558768]

Moist Heat or Steam Sterilization

[00885556558768]

Moist Heat or Steam Sterilization

[00885556558768]

Moist Heat or Steam Sterilization

[00885556558768]

Moist Heat or Steam Sterilization

[00885556558768]

Moist Heat or Steam Sterilization

[00885556558768]

Moist Heat or Steam Sterilization

[00885556558768]

Moist Heat or Steam Sterilization

[00885556558768]

Moist Heat or Steam Sterilization

[00885556558768]

Moist Heat or Steam Sterilization

[00885556558768]

Moist Heat or Steam Sterilization

[00885556558768]

Moist Heat or Steam Sterilization

[00885556558768]

Moist Heat or Steam Sterilization

[00885556558768]

Moist Heat or Steam Sterilization

[00885556558768]

Moist Heat or Steam Sterilization

[00885556558768]

Moist Heat or Steam Sterilization

[00885556558768]

Moist Heat or Steam Sterilization

[00885556558768]

Moist Heat or Steam Sterilization

[00885556558768]

Moist Heat or Steam Sterilization

[00885556558768]

Moist Heat or Steam Sterilization

[00885556558768]

Moist Heat or Steam Sterilization

[00885556558768]

Moist Heat or Steam Sterilization

[00885556558768]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-11-22
• Device Publish Date: 2017-09-21

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)