PROPHECY

GUDID 00840420185662

WRIGHT MEDICAL TECHNOLOGY, INC.

Custom-made orthopaedic surgical guide, non-sterile Custom-made orthopaedic/craniofacial surgical guide Custom-made orthopaedic/craniofacial surgical guide Custom-made orthopaedic/craniofacial surgical guide Custom-made orthopaedic/craniofacial surgical guide Custom-made orthopaedic/craniofacial surgical guide Custom-made orthopaedic/craniofacial surgical guide Custom-made orthopaedic/craniofacial surgical guide Custom-made orthopaedic/craniofacial surgical guide Custom-made orthopaedic/craniofacial surgical guide Custom-made orthopaedic/craniofacial surgical guide Custom-made orthopaedic/craniofacial surgical guide Custom-made orthopaedic/craniofacial surgical guide Custom-made orthopaedic/craniofacial surgical guide Custom-made orthopaedic/craniofacial surgical guide Custom-made orthopaedic/craniofacial surgical guide Custom-made orthopaedic/craniofacial surgical guide Custom-made orthopaedic/craniofacial surgical guide Custom-made orthopaedic/craniofacial surgical guide Custom-made orthopaedic/craniofacial surgical guide Custom-made orthopaedic/craniofacial surgical guide Custom-made orthopaedic/craniofacial surgical guide

• Primary Device ID: 00840420185662
• NIH Device Record Key: d26ddfa5-d084-4513-a3c3-159891046820
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PROPHECY
• Version Model Number: PROPRPT
• 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
• 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
• 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 Identifiers

Device Issuing Agency	Device ID
GS1	00840420185662 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K162795

FDA Product Code

• HNS: Expressor

Sterilization

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

[00840420185662]

Moist Heat or Steam Sterilization

[00840420185662]

Moist Heat or Steam Sterilization

[00840420185662]

Moist Heat or Steam Sterilization

[00840420185662]

Moist Heat or Steam Sterilization

[00840420185662]

Moist Heat or Steam Sterilization

[00840420185662]

Moist Heat or Steam Sterilization

[00840420185662]

Moist Heat or Steam Sterilization

[00840420185662]

Moist Heat or Steam Sterilization

[00840420185662]

Moist Heat or Steam Sterilization

[00840420185662]

Moist Heat or Steam Sterilization

[00840420185662]

Moist Heat or Steam Sterilization

[00840420185662]

Moist Heat or Steam Sterilization

[00840420185662]

Moist Heat or Steam Sterilization

[00840420185662]

Moist Heat or Steam Sterilization

[00840420185662]

Moist Heat or Steam Sterilization

[00840420185662]

Moist Heat or Steam Sterilization

[00840420185662]

Moist Heat or Steam Sterilization

[00840420185662]

Moist Heat or Steam Sterilization

[00840420185662]

Moist Heat or Steam Sterilization

[00840420185662]

Moist Heat or Steam Sterilization

[00840420185662]

Moist Heat or Steam Sterilization

[00840420185662]

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: 2017-03-20

On-Brand Devices [PROPHECY]

• 00840420185662: PROPRPT
• 00889797075510: Adapter Insert
• 00889797075503: Adapter Insert
• 00889797075497: Screw Adjust Adapter
• 00889797075480: C-Bracket Adapter
• 00889797110150: Prophecy® 3D Planner