ZUK 00584209410

GUDID 00885556621011

Vivacit-E Articular Surface Size 4 10mm

Smith & Nephew, Inc.

Unicondylar knee insert

• Primary Device ID: 00885556621011
• NIH Device Record Key: b476dbd1-e725-4044-a100-87c9798c9017
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ZUK
• Version Model Number: 00584209410
• Catalog Number: 00584209410
• Company DUNS: 109903521
• 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
• 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	00885556621011 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K122529

FDA Product Code

• HSX: PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-02-15

On-Brand Devices [ZUK]

• 00885556731475: ZUK SPACER BLOCK 11MM
• 00885556731468: ZUK SPCER BLOCK 9MM
• 00885556728871: ZUK SPACER BLOCK - 9MM
• 00885556728864: ZUK SPACER BLOCK - 11MM
• 00885556717264: RT 5-6 UNI TIBIA SIZER AND DRILL GUIDE
• 00885556717257: RT 3-4 UNI TIBIA SIZER AND DRILL GUIDE
• 00885556717240: RT 1-2 UNI TIBIA SIZER AND DRILL GUIDE
• 00885556717233: LT 5-6 UNI TIBIA SIZER AND DRILL GUIDE
• 00885556717226: LT 3-4 UNI TIBIA SIZER AND DRILL GUIDE
• 00885556717219: LT 1-2 UNI TIBIA SIZER AND DRILL GUIDE
• 00885556717202: RT UNI TIBIA KEEL PUNCH
• 00885556717196: LT UNI TIBIA KEEL PUNCH
• 00885556716113: ZUK SPACER BLOCK - 11MM
• 00885556716106: ZUK SPACER BLOCK - 9MM
• 00885556689813: ZUK FEMORAL/TIBIAL COMBINED SIZER LL/RM
• 00885556689806: ZUK FEMORAL/TIBIAL COMBINED SIZER LM/RL
• 00885556689790: ZUK TIBIAL SIZING TEMPLATE SZ 6
• 00885556689783: ZUK TIBIAL SIZING TEMPLATE SZ 5
• 00885556689769: ZUK TIBIAL SIZING TEMPLATE SZ 3
• 00885556689752: ZUK TIBIAL SIZING TEMPLATE SZ 2
• 00885556689745: ZUK TIBIAL SIZING TEMPLATE SZ 1
• 00885556689707: ZUK SPACER BLOCK - 11MM
• 00885556689691: ZUK SPACER BLOCK - 9MM
• 00885556689639: ZUK SPACER BLOCK - 9MM
• 00885556658222: SMITH AND NEPHEWS ZUK TRAY LID
• 00885556658215: TIBIA INSTRUMENT AND TRIAL TRAY
• 00885556658208: TIBIA INSTRUMENT TRAY
• 00885556658192: FEMORAL INSTRUMENT TRAY
• 00885556657744: ZUK SPACER BLOCK - 9MM
• 00885556657737: ZUK SPACER BLOCK - 11MM
• 00885556657720: ZUK SPACER BLOCK - 11MM
• 00885556657713: ZUK SPACER BLOCK - 9MM
• 00885556621813: Long Headless Smooth Pin Gold
• 00885556621806: ZUK Ankle Clamp
• 20885556621794: MIS Z Retractor
• 00885556621783: MIS Small PCL Retractor
• 00885556621776: MIS Quad-Sparing Screw Inserter Extractor
• 00885556621769: MIS Quad-Sparing Headed Screw 48 MM Length
• 00885556621752: MIS Quad-Sparing Headed Screw 33 MM Length
• 00885556621745: Tibial Resection Guide
• 20885556621732: ZUK Short Headed Holding Pin 17mm
• 20885556621725: ZUK Short Headed Holding Pin
• 20885556621718: ZUK Short Headed Holding Pin 52mm
• 00885556621691: Headless Trocar Drill Pin 3.2 MM Diameter 75 MM Length
• 00885556621684: 2MM FEMORAL/TIBIAL RECUTTER
• 00885556621677: ZUK Insertion Handle
• 00885556621660: Tray/Articular Surface Inserter Tip
• 00885556621653: ZUK Articular Surface Inserter Handle
• 00885556621646: Zimmer Unicompartmental Femoral Reamer .270
• 00885556621639: Tibial Sizing Slider