Universal2 Total Wrist Implant System 264515S

GUDID 00885556865620

UNI2 SCREW. 4.5MM X 15MM STERILE

Smith & Nephew, Inc.

Total wrist prosthesis

• Primary Device ID: 00885556865620
• NIH Device Record Key: 4c5b60be-aa8c-428a-9a62-9ad4ab3acf83
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Universal2 Total Wrist Implant System
• Version Model Number: 264515S
• Catalog Number: 264515S
• 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	00885556865620 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K030037

FDA Product Code

• JWJ: Prosthesis, wrist, 3 part metal-plastic-metal articulation, semi-constrained

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: 2022-12-22

On-Brand Devices [Universal2 Total Wrist Implant System]

• 00885556865842: BROACH. LARGE RIGHT
• 00885556865835: BROACH. LARGE LEFT
• 00885556865828: BROACH. MEDIUM RIGHT
• 00885556865811: BROACH. MEDIUM LEFT
• 00885556865804: BROACH. SMALL RIGHT
• 00885556865798: BROACH. SMALL LEFT
• 00885556865781: BROACH. X-SMALL RIGHT
• 00885556865774: BROACH. X-SMALL LEFT
• 00885556865767: RADIAL CUTTING GUIDE-RT
• 00885556865750: RADIAL CUTTING GUIDE-LF
• 00885556865538: SHAFT. HEX DRIVER. 2.5
• 00885556865521: 6MM COUNTERSINK
• 00885556865484: CARPAL POLY IMPACTOR
• 00885556865477: T-HANDLE
• 00885556865453: CARPAL CUTTING GUIDE
• 00885556865408: RADIAL GUIDE BAR
• 00885556865354: GUIDE PLATE. LARGE
• 00885556865347: GUIDE PLATE. MEDIUM
• 00885556865330: GUIDE PLATE. SMALL
• 00885556865323: GUIDE PLATE. EXTRA-SMALL
• 00885556865385: DRILL BIT 4.5MM CAN.
• 00885556865378: DRILL BIT 3.5MM CAN.
• 00885556865361: DRILL BIT 2.5MM X 110MM
• 00885556865743: TRIAL. RADIAL LARGE. RIGHT
• 00885556865729: TRIAL. RADIAL MEDIUM. RIGHT
• 00885556865705: TRIAL. RADIAL SMALL. RIGHT
• 00885556865682: TRIAL. RADIAL X-SMALL. RIGHT
• 00885556865460: BROACH HANDLE
• 00885556865309: K-WIRE - 1.1MM
• 00885556865736: TRAIL RADIAL LARGE LEFT
• 00885556865712: TRAIL RADIAL MEDIUM LEFT
• 00885556865699: TRIAL RADIAL SMALL LEFT
• 00885556865675: TRIAL RADIAL X SMALL
• 00885556865668: UNI2 SCREW. 4.5MM X 35MM STERILE
• 00885556865651: UNI2 SCREW. 4.5MM X 30MM STERILE
• 00885556865644: UNI2 SCREW. 4.5MM X 25MM STERILE
• 00885556865637: UNI2 SCREW. 4.5MM X 20MM STERILE
• 00885556865620: UNI2 SCREW. 4.5MM X 15MM STERILE
• 00885556865613: RADIAL IMPLANT. LARGE RIGHT
• 00885556865606: RADIAL IMPLANT. LARGE LEFT
• 00885556865590: RADIAL IMPLANT. MEDIUM. RIGHT
• 00885556865583: RADIAL IMPLANT. MEDIUM. LEFT
• 00885556865576: RADIAL IMPLANT. SMALL. RIGHT
• 00885556865569: RADIAL IMPLANT. SMALL. LEFT
• 00885556865552: RADIAL IMPLANT X-SMALL RIGHT
• 00885556865545: RADIAL IMPLANT X-SMALL LEFT
• 00885556865514: AO QUICK COUPLE DRIVER
• 00885556865507: POLY IMPACTOR
• 00885556865491: RADIAL IMPACTOR
• 00885556865446: CARPAL GUIDE BAR. STANDARD