129937

GUDID 03596010087416

UNIVERSAL FEMORAL HEAD 28MM +8

Smith & Nephew, Inc.

Ceramic femoral head prosthesis

• Primary Device ID: 03596010087416
• NIH Device Record Key: fe0d1f48-07a0-4d2d-afeb-b22369924206
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 129937
• Catalog Number: 129937
• 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: 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
• Phone: +1(800)821-5700
• Email: gudid@smith-nephew.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	03596010087416 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K870128

FDA Product Code

• JDI: Prosthesis, hip, semi-constrained, metal/polymer, cemented

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-01-31
• Device Publish Date: 2015-08-25

Devices Manufactured by Smith & Nephew, Inc.

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• 00885556893821 - TRIGEN MAX: 2025-05-15 TRIGEN MAX TIBIA NAIL 11MM X 37CM LEFT
• 00885556893838 - TRIGEN MAX: 2025-05-15 TRIGEN MAX TIBIA NAIL 11MM X 38CM LEFT
• 00885556893845 - TRIGEN MAX: 2025-05-15 TRIGEN MAX TIBIA NAIL 11MM X 39CM LEFT
• 00885556893852 - TRIGEN MAX: 2025-05-15 TRIGEN MAX TIBIA NAIL 11MM X 40CM LEFT
• 00885556893869 - TRIGEN MAX: 2025-05-15 TRIGEN MAX TIBIA NAIL 11MM X 41CM LEFT
• 00885556893876 - TRIGEN MAX: 2025-05-15 TRIGEN MAX TIBIA NAIL 11MM X 42CM LEFT
• 00885556893999 - TRIGEN MAX: 2025-05-15 TRIGEN MAX TIBIA NAIL 11MM X 35CM RIGHT