71364006

GUDID 03596010199225

T-HANDLE

Smith & Nephew, Inc.

Surgical instrument handle, non-torque-limiting

• Primary Device ID: 03596010199225
• NIH Device Record Key: e29016fb-b085-480f-8366-ec43035ec03b
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 71364006
• Catalog Number: 71364006
• 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)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
• 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	03596010199225 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K123598

FDA Product Code

• JDG: Prosthesis, hip, femoral component, cemented, metal

Sterilization

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

[03596010199225]

Moist Heat or Steam Sterilization

[03596010199225]

Moist Heat or Steam Sterilization

[03596010199225]

Moist Heat or Steam Sterilization

[03596010199225]

Moist Heat or Steam Sterilization

[03596010199225]

Moist Heat or Steam Sterilization

[03596010199225]

Moist Heat or Steam Sterilization

[03596010199225]

Moist Heat or Steam Sterilization

[03596010199225]

Moist Heat or Steam Sterilization

[03596010199225]

Moist Heat or Steam Sterilization

[03596010199225]

Moist Heat or Steam Sterilization

[03596010199225]

Moist Heat or Steam Sterilization

[03596010199225]

Moist Heat or Steam Sterilization

[03596010199225]

Moist Heat or Steam Sterilization

[03596010199225]

Moist Heat or Steam Sterilization

[03596010199225]

Moist Heat or Steam Sterilization

[03596010199225]

Moist Heat or Steam Sterilization

[03596010199225]

Moist Heat or Steam Sterilization

[03596010199225]

Moist Heat or Steam Sterilization

[03596010199225]

Moist Heat or Steam Sterilization

[03596010199225]

Moist Heat or Steam Sterilization

[03596010199225]

Moist Heat or Steam Sterilization

[03596010199225]

Moist Heat or Steam Sterilization

[03596010199225]

Moist Heat or Steam Sterilization

[03596010199225]

Moist Heat or Steam Sterilization

[03596010199225]

Moist Heat or Steam Sterilization

[03596010199225]

Moist Heat or Steam Sterilization

[03596010199225]

Moist Heat or Steam Sterilization

[03596010199225]

Moist Heat or Steam Sterilization

[03596010199225]

Moist Heat or Steam Sterilization

[03596010199225]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-01-31
• Device Publish Date: 2015-08-30

Devices Manufactured by Smith & Nephew, Inc.

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• 00885556915288 - NA: 2024-12-25 LM/RL TIBIA ALIGNMENT GUIDE SHORT
• 00885556921517 - Trigen: 2024-12-10 Swivel Guide Bolt Wrench
• 00885556921388 - Legion: 2024-12-04 Legion AP Cutting Block - Size 8
• 00885556921395 - Legion: 2024-12-04 Legion AP Cutting Block - Size 7
• 00885556921401 - Legion: 2024-12-04 Legion AP Cutting Block - Size 6
• 00885556921418 - Legion: 2024-12-04 Legion AP Cutting Block - Size 5
• 00885556921449 - Trigen: 2024-12-04 12.5mm Rigid Entry Reamer