R2 E0015228-13

GUDID 00885556663721

R3 SCREW-IN TRIAL LINER 20¿6/58

Smith & Nephew, Inc.

Femoral head prosthesis trial

• Primary Device ID: 00885556663721
• NIH Device Record Key: 114fa56d-d2a4-4712-88b0-380f22f195c2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: R2
• Version Model Number: E0015228-13
• Catalog Number: E0015228-13
• 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)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM

Device Identifiers

Device Issuing Agency	Device ID
GS1	00885556663721 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K123598

FDA Product Code

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

Sterilization

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

[00885556663721]

Moist Heat or Steam Sterilization

[00885556663721]

Moist Heat or Steam Sterilization

[00885556663721]

Moist Heat or Steam Sterilization

[00885556663721]

Moist Heat or Steam Sterilization

[00885556663721]

Moist Heat or Steam Sterilization

[00885556663721]

Moist Heat or Steam Sterilization

[00885556663721]

Moist Heat or Steam Sterilization

[00885556663721]

Moist Heat or Steam Sterilization

[00885556663721]

Moist Heat or Steam Sterilization

[00885556663721]

Moist Heat or Steam Sterilization

[00885556663721]

Moist Heat or Steam Sterilization

[00885556663721]

Moist Heat or Steam Sterilization

[00885556663721]

Moist Heat or Steam Sterilization

[00885556663721]

Moist Heat or Steam Sterilization

[00885556663721]

Moist Heat or Steam Sterilization

[00885556663721]

Moist Heat or Steam Sterilization

[00885556663721]

Moist Heat or Steam Sterilization

[00885556663721]

Moist Heat or Steam Sterilization

[00885556663721]

Moist Heat or Steam Sterilization

[00885556663721]

Moist Heat or Steam Sterilization

[00885556663721]

Moist Heat or Steam Sterilization

[00885556663721]

Moist Heat or Steam Sterilization

[00885556663721]

Moist Heat or Steam Sterilization

[00885556663721]

Moist Heat or Steam Sterilization

[00885556663721]

Moist Heat or Steam Sterilization

[00885556663721]

Moist Heat or Steam Sterilization

[00885556663721]

Moist Heat or Steam Sterilization

[00885556663721]

Moist Heat or Steam Sterilization

[00885556663721]

Moist Heat or Steam Sterilization

[00885556663721]

Moist Heat or Steam Sterilization

[00885556663721]

Moist Heat or Steam Sterilization

[00885556663721]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-02-07
• Device Publish Date: 2016-10-24

Devices Manufactured by Smith & Nephew, Inc.

• 00885556917794 - EVOS: 2025-12-31 EVOS 3.5MM X 54MM CORTEX SCREW SELF-TAPPING
• 00885556915257 - NA: 2025-12-30 EM POSTERIOR SLOPE GUIDE SHORT
• 00885556915264 - NA: 2025-12-30 EM TIBIA ALIGNMENT TUBE MICRO SHORT
• 00885556915271 - NA: 2025-12-30 MACRO EM TIBIA ALIGNMENT TUBE SHORT
• 00885556915295 - NA: 2025-12-30 RM/LL TIBIA ALIGNMENT GUIDE SHORT
• 00885556915301 - NA: 2025-12-30 TIBIA ALIGNMENT ADJUSTMENT GUIDE SHORT
• 00885556915318 - NA: 2025-12-30 SYNC SHORT EXTRAMEDULLARY GUIDES MODULE
• 00885556900260 - TRIGEN MAX: 2025-12-26 TRIGEN MAX BUTTRESS PLATE - TI