VISIONAIRE V0100128

GUDID 00885556779989

VISIONAIRE UK MEDIALGUIDE KIT

Smith & Nephew, Inc.

Custom-made orthopaedic/craniofacial surgical guide

• Primary Device ID: 00885556779989
• NIH Device Record Key: 84339128-0aba-49fd-95e3-bd393c6d7041
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VISIONAIRE
• Version Model Number: V0100128
• Catalog Number: V0100128
• 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: true
• 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
• 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	00885556779989 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K211512

FDA Product Code

• JWH: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER

Sterilization

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

[00885556779989]

Moist Heat or Steam Sterilization

[00885556779989]

Moist Heat or Steam Sterilization

[00885556779989]

Moist Heat or Steam Sterilization

[00885556779989]

Moist Heat or Steam Sterilization

[00885556779989]

Moist Heat or Steam Sterilization

[00885556779989]

Moist Heat or Steam Sterilization

[00885556779989]

Moist Heat or Steam Sterilization

[00885556779989]

Moist Heat or Steam Sterilization

[00885556779989]

Moist Heat or Steam Sterilization

[00885556779989]

Moist Heat or Steam Sterilization

[00885556779989]

Moist Heat or Steam Sterilization

[00885556779989]

Moist Heat or Steam Sterilization

[00885556779989]

Moist Heat or Steam Sterilization

[00885556779989]

Moist Heat or Steam Sterilization

[00885556779989]

Moist Heat or Steam Sterilization

[00885556779989]

Moist Heat or Steam Sterilization

[00885556779989]

Moist Heat or Steam Sterilization

[00885556779989]

Moist Heat or Steam Sterilization

[00885556779989]

Moist Heat or Steam Sterilization

[00885556779989]

Moist Heat or Steam Sterilization

[00885556779989]

Moist Heat or Steam Sterilization

[00885556779989]

Moist Heat or Steam Sterilization

[00885556779989]

Moist Heat or Steam Sterilization

[00885556779989]

Moist Heat or Steam Sterilization

[00885556779989]

Moist Heat or Steam Sterilization

[00885556779989]

Moist Heat or Steam Sterilization

[00885556779989]

Moist Heat or Steam Sterilization

[00885556779989]

Moist Heat or Steam Sterilization

[00885556779989]

Moist Heat or Steam Sterilization

[00885556779989]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-09-30
• Device Publish Date: 2021-09-22

On-Brand Devices [VISIONAIRE]

• 00885556658499: NONSTERILE VISIONAIRE ADAPTIVE GUIDE KIT TC PLUS VKS MOBILE
• 00885556658482: NONSTERILE VISIONAIRE ADAPTIVE GUIDE PROXIMAL TIBIA TC PLUS
• 00885556658475: NONSTERILE VISIONAIRE ADAPTIVE GUIDE KIT TC PLUS VKS FIXED B
• 00885556658468: NONSTERILE VISIONAIRE ADAPTIVE GUIDE PROXIMAL TIBIA TC PLUS
• 00885556658451: NONSTERILE VISIONAIRE ADAPTIVE GUIDE KIT TC PLUS MOBILE BEAR
• 00885556658444: NONSTERILE VISIONAIRE ADAPTIVE GUIDE PROXIMAL TIBIA TC PLUS
• 00885556658437: NONSTERILE VISIONAIRE ADAPTIVE GUIDE KIT TC PLUS FIXED BEARI
• 00885556658420: NONSTERILE VISIONAIRE ADAPTIVE GUIDE PROXIMAL TIBIA TC PLUS
• 00885556658413: NONSTERILE VISIONAIRE ADAPTIVE GUIDE DISTAL FEMUR TC PLUS
• 00885556658406: NONSTERILE VISIONAIRE ADAPTIVE GUIDE KIT JOURNEY II
• 00885556658390: VISIONAIRE ADAPTIVE GUIDE PROXIMAL TIBIAL JOURNEY II
• 00885556656587: NONSTERILE VISIONAIRE ADAPTIVE GUIDE PROXIMAL TIBIAL JOURNEY
• 00885556656570: NONSTERILE VISIONAIRE ADAPTIVE GUIDE DISTAL FEMUR JOURNEY II
• 00885556656563: NONSTERILE VISIONAIRE ADAPTIVE GUIDE KIT LEGION PRIMARY
• 00885556656556: NONSTERILE VISIONAIRE ADAPTIVE GUIDE PROXIMAL TIBIA LEGION P
• 00885556656549: NONSTERILE VISIONAIRE ADAPTIVE GUIDE DISTAL FEMUR LEGION PRI
• 00885556656532: NONSTERILE VISIONAIRE ADAPTIVE GUIDE KIT GENESIS II
• 00885556656525: NONSTERILE VISIONAIRE ADAPTIVE GUIDE PROXIMAL TIBIA GENESIS
• 00885556656518: NONSTERILE VISIONAIRE ADAPTIVE GUIDE DISTAL FEMUR GENESIS II
• 00885556656501: VISIONAIRE ADAPTIVE GUIDE KIT TC PLUS VKS MOBILE BEARING
• 00885556656464: VISIONAIRE ADAPTIVE GUIDE KIT TC PLUS MOBILE BEARING
• 00885556656457: VISIONAIRE ADAPTIVE GUIDE PROXIMAL TIBIA TC PLUS MOBILE BEAR
• 00885556656440: VISIONAIRE ADAPTIVE GUIDE KIT TC PLUS FIXED BEARING
• 00885556656433: VISIONAIRE ADAPTIVE GUIDE PROXIMALTIBIA TC PLUS FIXED BEARIN
• 00885556656426: VISIONAIRE ADAPTIVE GUIDE DISTAL FEMUR TC PLUS
• 00885556656419: VISIONAIRE ADAPTIVE GUIDE KIT JOURNEY II
• 00885556656402: VISIONAIRE ADAPTIVE GUIDE DISTAL FEMUR JOURNEY II
• 00885556656396: VISIONAIRE ADAPTIVE GUIDE KIT LEGION PRIMARY
• 00885556656389: VISIONAIRE ADAPTIVE GUIDE PROXIMAL TIBIA LEGION PRIMARY
• 00885556656372: VISIONAIRE ADAPTIVE GUIDE DISTAL FEMUR LEGION PRIMARY
• 00885556656365: VISIONAIRE ADAPTIVE GUIDE KIT GENESIS II
• 00885556656358: VISIONAIRE ADAPTIVE GUIDE PROXIMAL TIBIA GENESIS II
• 00885556656341: VISIONAIRE ADAPTIVE GUIDE DISTAL FEMUR GENESIS II
• 00885556656273: VISIONAIRE ALIGNMENT CONNECTOR
• 00885556656266: VISIONAIRE LIGHTWEIGHT ALIGNMENT ROD
• 00885556780039: NONSTERILE VISIONAIRE UK MEDIAL GUIDE KIT
• 00885556779989: VISIONAIRE UK MEDIALGUIDE KIT