71342640

GUDID 00885556022603

40MM COCR MODULAR FEMORAL HEAD

Smith & Nephew, Inc.

Metallic femoral head prosthesis Metallic femoral head prosthesis Metallic femoral head prosthesis Metallic femoral head prosthesis Metallic femoral head prosthesis Metallic femoral head prosthesis Metallic femoral head prosthesis Metallic femoral head prosthesis Metallic femoral head prosthesis Metallic femoral head prosthesis Metallic femoral head prosthesis Metallic femoral head prosthesis Metallic femoral head prosthesis Metallic femoral head prosthesis Metallic femoral head prosthesis Metallic femoral head prosthesis Metallic femoral head prosthesis Metallic femoral head prosthesis Metallic femoral head prosthesis Metallic femoral head prosthesis Metallic femoral head prosthesis Metallic femoral head prosthesis Metallic femoral head prosthesis Metallic femoral head prosthesis Metallic femoral head prosthesis Metallic femoral head prosthesis Metallic femoral head prosthesis Metallic femoral head prosthesis Metallic femoral head prosthesis Metallic femoral head prosthesis Metallic femoral head prosthesis

• Primary Device ID: 00885556022603
• NIH Device Record Key: c764305d-dc36-4865-b666-f8d7c34ab8a4
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 71342640
• Catalog Number: 71342640
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00885556022603 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K093363

FDA Product Code

• MBL: Prosthesis, hip, semi-constrained, uncemented, metal/polymer, porous

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2015-08-30

Devices Manufactured by Smith & Nephew, Inc.

• 00885556902738 - INTELLIO SHIFT: 2024-05-15 NEO CONTROLLER REFURBISH
• 00885556630761 - Q-FIX: 2024-05-14 DISPOSABLE 1.8MM Q-FIX DRILL
• 00885556630785 - Q-FIX: 2024-05-14 REUSABLE 1.8MMQ-FIX DRILL GUIDE
• 00885556918333 - R3: 2024-05-10 FEMORAL OSTEOTOMY RULER
• 00885556817667 - TULA: 2024-05-07 TULA KIT- UNILATERAL (NST007068)
• 00885556890745 - Q-FIX: 2024-05-06 Q-FIX ULTRA
• 00885556890752 - ULTRABRACE: 2024-05-06 ULTRABRACE KIT
• 00885556890769 - FOOTPRINT: 2024-05-06 FOOTPRINT MINI PK 3.5MM