INVISION

GUDID 00840420186331

WRIGHT MEDICAL TECHNOLOGY, INC.

Fixed-bearing total ankle prosthesis

• Primary Device ID: 00840420186331
• NIH Device Record Key: 8c8dbe01-71e9-4d6e-b477-0087f2ca6b01
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: INVISION
• Version Model Number: 6000405L
• Company DUNS: 807201207
• Company Name: WRIGHT MEDICAL TECHNOLOGY, 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: true
• 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)238-7117
• Email: customerservice@wmt.com
• Phone: +1(800)238-7117
• Email: customerservice@wmt.com
• Phone: +1(800)238-7117
• Email: customerservice@wmt.com
• Phone: +1(800)238-7117
• Email: customerservice@wmt.com
• Phone: +1(800)238-7117
• Email: customerservice@wmt.com
• Phone: +1(800)238-7117
• Email: customerservice@wmt.com
• Phone: +1(800)238-7117
• Email: customerservice@wmt.com
• Phone: +1(800)238-7117
• Email: customerservice@wmt.com

Device Dimensions

• Device Size Text, specify: 0
• Height: 3 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Height: 3 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Height: 3 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Height: 3 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Height: 3 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Height: 3 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Height: 3 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840420186331 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K153008

FDA Product Code

• HSN: PROSTHESIS, ANKLE, SEMI-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: 2016-09-17

On-Brand Devices [INVISION]

• 00889797065436: 60006018
• 00889797023979: 60006005
• 00889797023962: 60006004
• 00889797023955: 60006003
• 00889797023948: 60006002
• 00889797023924: 60006000
• 00889797065450: 60006020
• 00889797065443: 60006019
• 00889797065382: 60006011
• 00840420194657: 60006024
• 00840420194534: IB220705
• 00840420194527: IB220704
• 00840420194510: IB220703
• 00840420194503: IB220702
• 00840420194497: IB220701
• 00840420194435: 60011150
• 00840420194428: 60011140
• 00840420194411: 60011130
• 00840420194404: 60011120
• 00840420194398: 60011110
• 00840420194299: 60011050
• 00840420194282: 60011040
• 00840420194275: 60011030
• 00840420194268: 60011020
• 00840420194251: 60011010
• 00840420194121: 60025800
• 00840420194114: 60025400
• 00840420194107: 60024800
• 00840420194091: 60024400
• 00840420194060: 60023800
• 00840420194053: 60023400
• 00840420194046: 60022800
• 00840420194039: 60022400
• 00840420194022: 60006023
• 00840420193964: 60012005
• 00840420193957: 60012004
• 00840420193940: 60012003
• 00840420193766: 60012002
• 00840420193759: 60012001
• 00840420187628: 6006515L
• 00840420187611: 6006514L
• 00840420187604: 6006513L
• 00840420187598: 6006512L
• 00840420187581: 6006511L
• 00840420187574: 6006514R
• 00840420187567: 6006513R
• 00840420187550: 6006512R
• 00840420187543: 6006511R
• 00840420187536: 6006505L
• 00840420187529: 6006504L