PROPHECY INVISION

GUDID 00840420194725

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

• Primary Device ID: 00840420194725
• NIH Device Record Key: 1600766f-583c-4745-bf8f-d1256ded1a71
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PROPHECY INVISION
• Version Model Number: PROPINV
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840420194725 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K170968

FDA Product Code

• HSN: PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Sterilization

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

[00840420194725]

Moist Heat or Steam Sterilization

[00840420194725]

Moist Heat or Steam Sterilization

[00840420194725]

Moist Heat or Steam Sterilization

[00840420194725]

Moist Heat or Steam Sterilization

[00840420194725]

Moist Heat or Steam Sterilization

[00840420194725]

Moist Heat or Steam Sterilization

[00840420194725]

Moist Heat or Steam Sterilization

[00840420194725]

Moist Heat or Steam Sterilization

[00840420194725]

Moist Heat or Steam Sterilization

[00840420194725]

Moist Heat or Steam Sterilization

[00840420194725]

Moist Heat or Steam Sterilization

[00840420194725]

Moist Heat or Steam Sterilization

[00840420194725]

Moist Heat or Steam Sterilization

[00840420194725]

Moist Heat or Steam Sterilization

[00840420194725]

Moist Heat or Steam Sterilization

[00840420194725]

Moist Heat or Steam Sterilization

[00840420194725]

Moist Heat or Steam Sterilization

[00840420194725]

Moist Heat or Steam Sterilization

[00840420194725]

Moist Heat or Steam Sterilization

[00840420194725]

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: 2018-02-14

On-Brand Devices [PROPHECY INVISION]

• 00840420194725: PROPINV
• 00889797068376: PINV0075
• 00889797068369: PINV0074
• 00889797068352: PINV0064
• 00889797068345: PINV1000
• 00889797068338: PINV5000
• 00889797068321: PINV4000
• 00889797068314: PINV3000
• 00889797068307: PINV2000