71354177

GUDID 00885556024423

MDF TRIAL NECK HIGH OFFSET

Smith & Nephew, Inc.

Femoral stem prosthesis trial

• Primary Device ID: 00885556024423
• NIH Device Record Key: 50e6de02-7e1d-4447-8c94-f7ecfab2a6ac
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 71354177
• Catalog Number: 71354177
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00885556024423 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K113789

FDA Product Code

• LZO: Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented

Sterilization

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

[00885556024423]

Moist Heat or Steam Sterilization

[00885556024423]

Moist Heat or Steam Sterilization

[00885556024423]

Moist Heat or Steam Sterilization

[00885556024423]

Moist Heat or Steam Sterilization

[00885556024423]

Moist Heat or Steam Sterilization

[00885556024423]

Moist Heat or Steam Sterilization

[00885556024423]

Moist Heat or Steam Sterilization

[00885556024423]

Moist Heat or Steam Sterilization

[00885556024423]

Moist Heat or Steam Sterilization

[00885556024423]

Moist Heat or Steam Sterilization

[00885556024423]

Moist Heat or Steam Sterilization

[00885556024423]

Moist Heat or Steam Sterilization

[00885556024423]

Moist Heat or Steam Sterilization

[00885556024423]

Moist Heat or Steam Sterilization

[00885556024423]

Moist Heat or Steam Sterilization

[00885556024423]

Moist Heat or Steam Sterilization

[00885556024423]

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.

• 00885556921562 - LEGION: 2025-04-21 LEGION MEDIAL STABILIZED XLPE INSERT W/ JRNY LOCK RIGHT SZ 1-2 11MM
• 00885556921579 - LEGION: 2025-04-21 LEGION MEDIAL STABILIZED XLPE INSERT W/ JRNY LOCK RIGHT SZ 1-2 12MM
• 00885556921586 - LEGION: 2025-04-21 LEGION MEDIAL STABILIZED XLPE INSERT W/ JRNY LOCK RIGHT SZ 1-2 13MM
• 00885556921593 - LEGION: 2025-04-21 LEGION MEDIAL STABILIZED XLPE INSERT W/ JRNY LOCK RIGHT SZ 1-2 15MM
• 00885556921609 - LEGION: 2025-04-21 LEGION MEDIAL STABILIZED XLPE INSERT W/ JRNY LOCK RIGHT SZ 1-2 18MM
• 00885556921616 - LEGION: 2025-04-21 LEGION MEDIAL STABILIZED XLPE INSERT W/ JRNY LOCK RIGHT SZ 3-4 9MM
• 00885556921623 - LEGION: 2025-04-21 LEGION MEDIAL STABILIZED XLPE INSERT W/ JRNY LOCK RIGHT SZ 3-4 10MM
• 00885556921630 - LEGION: 2025-04-21 LEGION MEDIAL STABILIZED XLPE INSERT W/ JRNY LOCK RIGHT SZ 3-4 11MM