71927097

GUDID 00885556044629

X LARGE RADIAL HEAD PROSTHESIS - CO CR

Smith & Nephew, Inc.

Elbow radius prosthesis Elbow radius prosthesis Elbow radius prosthesis Elbow radius prosthesis Elbow radius prosthesis Elbow radius prosthesis Elbow radius prosthesis Elbow radius prosthesis Elbow radius prosthesis Elbow radius prosthesis Elbow radius prosthesis Elbow radius prosthesis Elbow radius prosthesis Elbow radius prosthesis Elbow radius prosthesis Elbow radius prosthesis Elbow radius prosthesis Elbow radius prosthesis Elbow radius prosthesis Elbow radius prosthesis Elbow radius prosthesis Elbow radius prosthesis Elbow radius prosthesis Elbow radius prosthesis Elbow radius prosthesis Elbow radius prosthesis Elbow radius prosthesis Elbow radius prosthesis Elbow radius prosthesis Elbow radius prosthesis Elbow radius prosthesis Elbow radius prosthesis

• Primary Device ID: 00885556044629
• NIH Device Record Key: 53744f87-da1b-4946-82d8-2858b21ee25f
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 71927097
• Catalog Number: 71927097
• 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)821-5700
• Email: gudid@smith-nephew.com
• Phone: +1(800)821-5700
• 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	00885556044629 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K992220

FDA Product Code

• KWI: PROSTHESIS, ELBOW, HEMI-, RADIAL, POLYMER

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-01-31
• Device Publish Date: 2015-08-29

Devices Manufactured by Smith & Nephew, Inc.

• 00885556747353 - FASTPAK: 2024-06-21 FASTPAK TIBIAL BASE TRIAL SIZE 1 LEFT
• 00885556747360 - FASTPAK: 2024-06-21 FASTPAK TIBIAL BASE TRIAL SIZE 2 LEFT
• 00885556747377 - FASTPAK: 2024-06-21 FASTPAK TIBIAL BASE TRIAL SIZE 3 LEFT
• 00885556747384 - FASTPAK: 2024-06-21 FASTPAK TIBIAL BASE TRIAL SIZE 5 LEFT
• 00885556747407 - FASTPAK: 2024-06-21 FASTPAK TIBIAL BASE TRIAL SIZE 1 RIGHT
• 00885556747414 - FASTPAK: 2024-06-21 FASTPAK TIBIAL BASE TRIAL SIZE 2 RIGHT
• 00885556747421 - FASTPAK: 2024-06-21 FASTPAK TIBIAL BASE TRIAL SIZE 3 RIGHT
• 00885556747438 - FASTPAK: 2024-06-21 FASTPAK TIBIAL BASE TRIAL SIZE 4 RIGHT