71350385

GUDID 00885556338247

RADIOPAQUE TRIAL NECK HIGH OFFSET

Smith & Nephew, Inc.

Femoral stem prosthesis trial

• Primary Device ID: 00885556338247
• NIH Device Record Key: 0aeb3127-6c34-4255-8b11-25b3ce5d0e33
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 71350385
• Catalog Number: 71350385
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00885556338247 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K113039

FDA Product Code

• LPH: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Sterilization

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

[00885556338247]

Moist Heat or Steam Sterilization

[00885556338247]

Moist Heat or Steam Sterilization

[00885556338247]

Moist Heat or Steam Sterilization

[00885556338247]

Moist Heat or Steam Sterilization

[00885556338247]

Moist Heat or Steam Sterilization

[00885556338247]

Moist Heat or Steam Sterilization

[00885556338247]

Moist Heat or Steam Sterilization

[00885556338247]

Moist Heat or Steam Sterilization

[00885556338247]

Moist Heat or Steam Sterilization

[00885556338247]

Moist Heat or Steam Sterilization

[00885556338247]

Moist Heat or Steam Sterilization

[00885556338247]

Moist Heat or Steam Sterilization

[00885556338247]

Moist Heat or Steam Sterilization

[00885556338247]

Moist Heat or Steam Sterilization

[00885556338247]

Moist Heat or Steam Sterilization

[00885556338247]

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.

• 00885556894279 - NA: 2025-05-23 TRIGEN MAX 0MM NAIL CAP
• 00885556894286 - NA: 2025-05-23 TRIGEN MAX 5MM NAIL CAP
• 00885556894293 - NA: 2025-05-23 TRIGEN MAX 10MM NAIL CAP
• 00885556894309 - NA: 2025-05-23 TRIGEN MAX 15MM NAIL CAP
• 00885556894316 - NA: 2025-05-23 TRIGEN MAX 20MM NAIL CAP
• 00885556895528 - TRIGEN MAX: 2025-05-22 TRIGEN MAX COMPRESSION SET SCREW (3.5MM HEX)
• 00885556892954 - TRIGEN MAX: 2025-05-20 TRIGEN MAX TIBIA NAIL 9MM X 29CM LEFT
• 00885556894552 - NA: 2025-05-20 TRIGEN MAX 5.0MM LOCKING SCREW - 77.5MM