VISIONAIRE GENESIS II V0200001

GUDID 00885556583005

NON STERILE VISIONAIRE DISTAL FEMUR CUTTING BLOCK - GENESIS II

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: 00885556583005
• NIH Device Record Key: c22b9aac-7aa3-421b-ab4f-cc6d28fc5762
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VISIONAIRE GENESIS II
• Version Model Number: V0200001
• Catalog Number: V0200001
• 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 Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00885556583005 [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

[00885556583005]

Moist Heat or Steam Sterilization

[00885556583005]

Moist Heat or Steam Sterilization

[00885556583005]

Moist Heat or Steam Sterilization

[00885556583005]

Moist Heat or Steam Sterilization

[00885556583005]

Moist Heat or Steam Sterilization

[00885556583005]

Moist Heat or Steam Sterilization

[00885556583005]

Moist Heat or Steam Sterilization

[00885556583005]

Moist Heat or Steam Sterilization

[00885556583005]

Moist Heat or Steam Sterilization

[00885556583005]

Moist Heat or Steam Sterilization

[00885556583005]

Moist Heat or Steam Sterilization

[00885556583005]

Moist Heat or Steam Sterilization

[00885556583005]

Moist Heat or Steam Sterilization

[00885556583005]

Moist Heat or Steam Sterilization

[00885556583005]

Moist Heat or Steam Sterilization

[00885556583005]

Moist Heat or Steam Sterilization

[00885556583005]

Moist Heat or Steam Sterilization

[00885556583005]

Moist Heat or Steam Sterilization

[00885556583005]

Moist Heat or Steam Sterilization

[00885556583005]

Moist Heat or Steam Sterilization

[00885556583005]

Moist Heat or Steam Sterilization

[00885556583005]

Moist Heat or Steam Sterilization

[00885556583005]

Moist Heat or Steam Sterilization

[00885556583005]

Moist Heat or Steam Sterilization

[00885556583005]

Moist Heat or Steam Sterilization

[00885556583005]

Moist Heat or Steam Sterilization

[00885556583005]

Moist Heat or Steam Sterilization

[00885556583005]

Moist Heat or Steam Sterilization

[00885556583005]

Moist Heat or Steam Sterilization

[00885556583005]

Moist Heat or Steam Sterilization

[00885556583005]

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: 2015-09-28

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• 00885556583029: NON STERILE VISIONAIRE LEFT CUTTING BLOCK KIT - GENESIS II
• 00885556583012: NON STERILE VISIONAIRE PROXIMAL TIBIA CUTTING BLOCK - GENESI
• 00885556583005: NON STERILE VISIONAIRE DISTAL FEMUR CUTTING BLOCK - GENESIS
• 00885556076712: VISIONAIRE PROXIMAL TIBIA CUTTING BLOCK - GENESIS II
• 00885556076354: VISIONAIRE DISTAL FEMUR CUTTING BLOCK - GENESIS II
• 03596010653123: VISIONAIRE RIGHT CUTTING BLOCK KIT - GENESIS II
• 03596010653116: VISIONAIRE LEFT CUTTING BLOCK KIT - GENESIS II