71355111

GUDID 00885556223840

RADIOPAQUE TRIAL NECK HIGH OFFSET+10MM

Smith & Nephew, Inc.

General internal orthopaedic fixation system implantation kit

• Primary Device ID: 00885556223840
• NIH Device Record Key: 37efaa59-1ea6-4643-ba0b-ab5cb995cfad
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 71355111
• Catalog Number: 71355111
• 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	00885556223840 [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

[00885556223840]

Moist Heat or Steam Sterilization

[00885556223840]

Moist Heat or Steam Sterilization

[00885556223840]

Moist Heat or Steam Sterilization

[00885556223840]

Moist Heat or Steam Sterilization

[00885556223840]

Moist Heat or Steam Sterilization

[00885556223840]

Moist Heat or Steam Sterilization

[00885556223840]

Moist Heat or Steam Sterilization

[00885556223840]

Moist Heat or Steam Sterilization

[00885556223840]

Moist Heat or Steam Sterilization

[00885556223840]

Moist Heat or Steam Sterilization

[00885556223840]

Moist Heat or Steam Sterilization

[00885556223840]

Moist Heat or Steam Sterilization

[00885556223840]

Moist Heat or Steam Sterilization

[00885556223840]

Moist Heat or Steam Sterilization

[00885556223840]

Moist Heat or Steam Sterilization

[00885556223840]

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

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• 00885556915875 - DIRECT VIEW AND VIDEO SCOPES: 2025-07-01 4KO VIDIOARTHROSCOPE AC 4 X 30 DEG X 160MM REVERSE POST
• 00885556915882 - DIRECT VIEW AND VIDEO SCOPE: 2025-07-01 4KO VIDEOARTHROSCOPE AC 4 X 70 DEG X 160MM REVERSE POST
• 00885556915899 - DIRECT VIEW AND VIDEO SCOPES: 2025-07-01 SERVICE REPLACEMENT 4KO VAS AC 4X 30 DEG X 160MM REVERSE POST
• 00885556915905 - DIRECT VIEW AND VIDEO SCOPE: 2025-07-01 SERVICE REPLACEMENT 4KO VAS AC 4 X 70 DEG X 160MM RND TIP REV POST
• 00885556900284 - TRIGEN MAX: 2025-06-10 TRIGEN MAX 13MM WASHER
• 00885556901960 - EVOS: 2025-06-02 EVOS PELVIC 2.7MM X 26MM CORTEX SCREW BLUNT TIP