71353203

GUDID 03596010198297

TRIAL 12/14 TAPER FEMORAL HEAD 32MM -3

Smith & Nephew, Inc.

Femoral head prosthesis trial

• Primary Device ID: 03596010198297
• NIH Device Record Key: a11dc3e9-b096-45a6-a369-810c063b0239
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 71353203
• Catalog Number: 71353203
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	03596010198297 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K121393

FDA Product Code

• HRY: PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Sterilization

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

[03596010198297]

Moist Heat or Steam Sterilization

[03596010198297]

Moist Heat or Steam Sterilization

[03596010198297]

Moist Heat or Steam Sterilization

[03596010198297]

Moist Heat or Steam Sterilization

[03596010198297]

Moist Heat or Steam Sterilization

[03596010198297]

Moist Heat or Steam Sterilization

[03596010198297]

Moist Heat or Steam Sterilization

[03596010198297]

Moist Heat or Steam Sterilization

[03596010198297]

Moist Heat or Steam Sterilization

[03596010198297]

Moist Heat or Steam Sterilization

[03596010198297]

Moist Heat or Steam Sterilization

[03596010198297]

Moist Heat or Steam Sterilization

[03596010198297]

Moist Heat or Steam Sterilization

[03596010198297]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 6
• Public Version Date: 2020-01-31
• Device Publish Date: 2015-08-30

Devices Manufactured by Smith & Nephew, Inc.

• 00885556897102 - INTERTAN MAX: 2025-11-19 INTERTAN MAX 10MM X 24CM X 125D LEFT
• 00885556897119 - INTERTAN MAX: 2025-11-19 INTERTAN MAX 10MM X 24CM X 125D RIGHT
• 00885556897126 - INTERTAN MAX: 2025-11-19 INTERTAN MAX 11.5MM X 24CM X 125D LEFT
• 00885556897133 - INTERTAN MAX: 2025-11-19 INTERTAN MAX 11.5MM X 24CM X 125D RIGHT
• 00885556897201 - INTERTAN MAX: 2025-11-19 INTERTAN MAX 9MM X 38CM X 125D LEFT
• 00885556897218 - INTERTAN MAX: 2025-11-19 INTERTAN MAX 9MM X 40CM X 125D LEFT
• 00885556897225 - INTERTAN MAX: 2025-11-19 INTERTAN MAX 9MM X 42CM X 125D LEFT
• 00885556897232 - INTERTAN MAX: 2025-11-19 INTERTAN MAX 9MM X 44CM X 125D LEFT