Universal2 Total Wrist Implant System 262101

GUDID 00885556864968

CARP POLY. EX-SMALL +1

Smith & Nephew, Inc.

Total wrist prosthesis Total wrist prosthesis Total wrist prosthesis Total wrist prosthesis Total wrist prosthesis Total wrist prosthesis Total wrist prosthesis Total wrist prosthesis Total wrist prosthesis Total wrist prosthesis Total wrist prosthesis Total wrist prosthesis Total wrist prosthesis Total wrist prosthesis

• Primary Device ID: 00885556864968
• NIH Device Record Key: df00b574-0fa8-4887-a839-b3f32b61451e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Universal2 Total Wrist Implant System
• Version Model Number: 262101
• Catalog Number: 262101
• 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	00885556864968 [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