PROPHECY INVISION

Basic Information

• Brand Name: PROPHECY INVISION
• Primary DI: 00840420194725
• Version / Model: PROPINV
• Catalog Number: PROPINV
• Company Name: WRIGHT MEDICAL TECHNOLOGY, INC.
• Labeler DUNS: 807201207
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-02-14
• Public Version: 5
• Public Version Date: 2022-05-24
• Public Version Status: Update
• Public Device Record Key: 1600766f-583c-4745-bf8f-d1256ded1a71

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: Yes
• Sterilization Methods: Moist Heat or Steam Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
HSN	PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER	Orthopedic	888.3110	2
OYK	Ankle arthroplasty implantation system	Orthopedic	888.3110	2

GMDN Terms

Code	Name	Definition	Implantable	Status
60826	Custom-made orthopaedic/craniofacial surgical guide	A custom-made surgical instrument intended to be used in an orthopaedic and/or craniomaxillofacial procedure (e.g., osteotomy, arthroplasty, tumour resection, distraction osteogenesis, cranial vault reconstruction) to assist in the intraoperative orientation of implant components, outlining the desired cut-line, and/or guiding of surgical instruments (e.g., surgical drill, oscillating cutting saw). It is made of synthetic polymer materials and is typically manufactured by 3-D printing and CAD/CAM techniques to match the patient-specific contours of the target anatomical site. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00840420194725	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]