First Choice Partial Ulnar Head Implant DRUJ-610-1945-WW

GUDID 00885556826553

FIRST CHOICE HEAD 19.0-STEM 4.5

Smith & Nephew, Inc.

Wrist ulna-head prosthesis

• Primary Device ID: 00885556826553
• NIH Device Record Key: 29c00ea8-b844-4f64-8a6e-f724ee8d662f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: First Choice Partial Ulnar Head Implant
• Version Model Number: DRUJ-610-1945-WW
• Catalog Number: DRUJ-610-1945-WW
• Company DUNS: 045483575
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00885556826553 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K112481

FDA Product Code

• KXE: Prosthesis, wrist, hemi-, ulnar

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2023-09-07
• Device Publish Date: 2022-12-21

On-Brand Devices [First Choice Partial Ulnar Head Implant]

• 00885556826331: DRUJ OSTEOTOMY GUIDE
• 00885556826577: FIRST CHOICE HEAD 19.0-STEM 6.5
• 00885556826560: FIRST CHOICE HEAD 19.0-STEM 5.5
• 00885556826553: FIRST CHOICE HEAD 19.0-STEM 4.5
• 00885556826546: FIRST CHOICE HEAD 17.5-STEM 6.5
• 00885556826539: FIRST CHOICE HEAD 17.5-STEM 5.5
• 00885556826522: FIRST CHOICE HEAD 17.5-STEM 4.5
• 00885556826515: FIRST CHOICE HEAD 16.0-STEM 6.5
• 00885556826508: FIRST CHOICE HEAD 16.0-STEM 5.5
• 00885556826492: FIRST CHOICE HEAD 16.0-STEM 4.5
• 00885556826485: FIRST CHOICE HEAD 14.5-STEM 6.5
• 00885556826478: FIRST CHOICE HEAD 14.5-STEM 5.5
• 00885556826461: FIRST CHOICE HEAD 14.5-STEM 4.5
• 00885556826454: DRUJ TRIAL SZ. 190-65
• 00885556826447: DRUJ TRIAL SZ. 190-55
• 00885556826430: DRUJ TRIAL SZ. 190-45
• 00885556826423: DRUJ TRIAL SZ. 175-65
• 00885556826416: DRUJ TRIAL SZ. 175-55
• 00885556826409: DRUJ TRIAL SZ. 175-45
• 00885556826393: DRUJ TRIAL SZ. 160-65
• 00885556826386: DRUJ TRIAL SZ. 160-55
• 00885556826379: DRUJ TRIAL SZ. 160-45
• 00885556826362: DRUJ TRIAL SZ. 145-65
• 00885556826355: DRUJ TRIAL SZ. 145-55
• 00885556826348: DRUJ TRIAL SZ. 145-45
• 00885556826119: FIRST CHOICE/DRUJ SYSTEM TAG
• 00885556826102: FIRST CHOICE INSERT