Freedom Wrist Arthroplasty System 348002E

GUDID 00885556855843

CARPAL PLATE. SIZE 2

Smith & Nephew, Inc.

Total wrist prosthesis

• Primary Device ID: 00885556855843
• NIH Device Record Key: c60dbf7d-9882-4521-8ee4-dfec1781a6fc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Freedom Wrist Arthroplasty System
• Version Model Number: 348002E
• Catalog Number: 348002E
• 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	00885556855843 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K132250

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 [Freedom Wrist Arthroplasty System]

• 00885556855539: RADIAL DRILL GUIDE. RIGHT
• 00885556855522: RADIAL DRILL GUIDE. LEFT
• 00885556855515: RADIAL TRIAL REMOVER
• 00885556855386: RADIAL RESECTION GUIDE SIZE 3
• 00885556855379: RADIAL RESECTION GUIDE SIZE 2
• 00885556855362: RADIAL RESECTION GUIDE SIZE 1
• 00885556855355: RADIAL FEELER
• 00885556855348: RADIAL IM GUIDE ROD
• 00885556855331: RADIAL TEMPLATE SIZE 3
• 00885556855324: RADIAL TEMPLATE SIZE 2
• 00885556855317: RADIAL TEMPLATE SIZE 1
• 00885556855232: RADIAL TRIAL. SIZE 3. RIGHT
• 00885556855225: RADIAL TRIAL. SIZE 3. LEFT
• 00885556855218: RADIAL TRIAL. SIZE 2. RIGHT
• 00885556855201: RADIAL TRIAL. SIZE 2. LEFT
• 00885556855195: RADIAL TRIAL. SIZE 1. RIGHT
• 00885556855171: 2.5MM HEX DRIVER
• 00885556855164: T15 STAR DRIVER
• 00885556855126: K-WIRE DEPTH GAUGE
• 00885556855102: TISSUE PROTECTIVE SLEEVE
• 00885556855096: CARPAL POLY IMPACTOR
• 00885556855089: CARPAL PLATE IMPACTOR
• 00885556855072: CARPAL CEMENT REAMER
• 00885556855065: CARPAL REAMER SIZE 3
• 00885556855058: CARPAL REAMER SIZE 2
• 00885556855041: CARPAL REAMER SIZE 1
• 00885556855027: CARPAL RESECTION GUIDE
• 00885556854990: MODULAR DRILL GUIDE
• 00885556854983: CARPAL SIZER
• 00885556855140: 3.5MM CANNULATED DRILL BIT
• 00885556855652: INSTRUMENT CASE INSERT
• 00885556855546: ANTI-ROTATION PIN
• 00885556855119: K-WIRE 150 MM. 1.4 MM DIAMETER
• 00885556855034: HAMATE FEELER
• 00885556856178: 4.5MM SCREW AND LOCKING CAP 45MM LENGTH
• 00885556856161: 4.5MM SCREW AND LOCKING CAP 40MM LENGTH
• 00885556856154: 4.5MM SCREW AND LOCKING CAP 35MM LENGTH
• 00885556856147: 4.5MM SCREW AND LOCKING CAP 30MM LENGTH
• 00885556856130: 4.5MM SCREW AND LOCKING CAP 25MM LENGTH
• 00885556856123: 4.5MM SCREW AND LOCKING CAP 20MM LENGTH
• 00885556856116: 4.5MM SCREW AND LOCKING CAP 17.5MM LENGTH
• 00885556856109: 4.5MM SCREW AND LOCKING CAP 15MM LENGTH
• 00885556856093: CARPAL POLY. SIZE 3. +4 MM
• 00885556856086: CARPAL POLY. SIZE 3. +2 MM
• 00885556856079: CARPAL POLY. SIZE 3. STANDARD
• 00885556856062: CARPAL POLY. SIZE 2. +4 MM
• 00885556856055: CARPAL POLY. SIZE 2. +2 MM
• 00885556856048: CARPAL POLY. SIZE 2. STANDARD
• 00885556856031: CARPAL POLY. SIZE 1. +4 MM
• 00885556856024: CARPAL POLY. SIZE 1. +2 MM