VISIONAIRE Journey II V0200081

GUDID 00885556533451

Visionaire Proximal Tibial Cutting Block Journey II Non Sterile

Smith & Nephew, Inc.

Orthopaedic implant aiming/guiding block, reusable Orthopaedic implant aiming/guiding block, reusable Orthopaedic implant aiming/guiding block, reusable Orthopaedic implant aiming/guiding block, reusable Orthopaedic implant aiming/guiding block, reusable Orthopaedic implant aiming/guiding block, reusable Orthopaedic implant aiming/guiding block, reusable Orthopaedic implant aiming/guiding block, reusable Orthopaedic implant aiming/guiding block, reusable Orthopaedic implant aiming/guiding block, reusable Orthopaedic implant aiming/guiding block, reusable Orthopaedic implant aiming/guiding block, reusable Orthopaedic implant aiming/guiding block, reusable Orthopaedic implant aiming/guiding block, reusable Orthopaedic implant aiming/guiding block, reusable Orthopaedic implant aiming/guiding block, reusable Orthopaedic implant aiming/guiding block, reusable Orthopaedic implant aiming/guiding block, reusable Orthopaedic implant aiming/guiding block, reusable Orthopaedic implant aiming/guiding block, reusable Orthopaedic implant aiming/guiding block, reusable Orthopaedic implant aiming/guiding block, reusable Orthopaedic implant aiming/guiding block, reusable Orthopaedic implant aiming/guiding block, reusable Orthopaedic implant aiming/guiding block, reusable Orthopaedic implant aiming/guiding block, reusable Orthopaedic implant aiming/guiding block, reusable Orthopaedic implant aiming/guiding block, reusable Orthopaedic implant aiming/guiding block, reusable Orthopaedic implant aiming/guiding block, reusable Orthopaedic implant aiming/guiding block, reusable

• Primary Device ID: 00885556533451
• NIH Device Record Key: 5b8cc700-faca-4d95-8794-32285e92d913
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VISIONAIRE Journey II
• Version Model Number: V0200081
• Catalog Number: V0200081
• 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
• 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	00885556533451 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K082358

FDA Product Code

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

Sterilization

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

[00885556533451]

Moist Heat or Steam Sterilization

[00885556533451]

Moist Heat or Steam Sterilization

[00885556533451]

Moist Heat or Steam Sterilization

[00885556533451]

Moist Heat or Steam Sterilization

[00885556533451]

Moist Heat or Steam Sterilization

[00885556533451]

Moist Heat or Steam Sterilization

[00885556533451]

Moist Heat or Steam Sterilization

[00885556533451]

Moist Heat or Steam Sterilization

[00885556533451]

Moist Heat or Steam Sterilization

[00885556533451]

Moist Heat or Steam Sterilization

[00885556533451]

Moist Heat or Steam Sterilization

[00885556533451]

Moist Heat or Steam Sterilization

[00885556533451]

Moist Heat or Steam Sterilization

[00885556533451]

Moist Heat or Steam Sterilization

[00885556533451]

Moist Heat or Steam Sterilization

[00885556533451]

Moist Heat or Steam Sterilization

[00885556533451]

Moist Heat or Steam Sterilization

[00885556533451]

Moist Heat or Steam Sterilization

[00885556533451]

Moist Heat or Steam Sterilization

[00885556533451]

Moist Heat or Steam Sterilization

[00885556533451]

Moist Heat or Steam Sterilization

[00885556533451]

Moist Heat or Steam Sterilization

[00885556533451]

Moist Heat or Steam Sterilization

[00885556533451]

Moist Heat or Steam Sterilization

[00885556533451]

Moist Heat or Steam Sterilization

[00885556533451]

Moist Heat or Steam Sterilization

[00885556533451]

Moist Heat or Steam Sterilization

[00885556533451]

Moist Heat or Steam Sterilization

[00885556533451]

Moist Heat or Steam Sterilization

[00885556533451]

Moist Heat or Steam Sterilization

[00885556533451]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2015-11-20

On-Brand Devices [VISIONAIRE Journey II]

• 00885556533475: Visionaire Journey II¿utting Block Kit Right Non Sterile
• 00885556533468: Visionaire Journey II¿utting Block Kit Left Non Sterile
• 00885556533451: Visionaire Proximal Tibial Cutting Block Journey II Non Ste
• 00885556533420: Visionaire Distal Femoral Cutting Block Journey II Non Ster
• 00885556492703: Visionaire Femoral Cutting Block Journey II
• 00885556492697: Visionaire Tibial Cutting Block Journey II