Freedom Wrist Arthroplasty System 348003E

GUDID 00885556855850

CARPAL PLATE. SIZE 3

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: 00885556855850
• NIH Device Record Key: bea72aff-0f82-4a49-971a-d542362754f1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Freedom Wrist Arthroplasty System
• Version Model Number: 348003E
• Catalog Number: 348003E
• 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	00885556855850 [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