Home GUDID 00889797114820 PROPHECY INCOMPASS
Primary DI 00889797114820
Brand PROPHECY INCOMPASS
Company WRIGHT MEDICAL TECHNOLOGY, INC.
Model PROPINC
Catalog number PROPINC
Device description Patient-Specific Guides
Published 2026-06-23
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
OTC false
Sterile false
Single use true
Product Codes# Code, Name table Code Name HSN PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class HSN Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer Orthopedic 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00889797114820 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 00889797114820 00889797114820 889797114820 0889797114820
GMDN Terms# Term, Definition table Term Definition 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.
Sterilization Methods# Method table Method Moist Heat or Steam Sterilization
Regulatory Flags# DUNS number 807201207 Device count 1 DM exempt false Premarket exempt false HCT/P false Kit false Combination product false Lot or batch true Serial number false Manufacturing date on label true Expiration date on label true Donation ID number false Contains natural rubber latex false No natural rubber latex false Sterilization required before use true Other Devices From This Company# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 00840097534237 Kinos Aeros Total Ankle Replacement Restor3d, Inc. HSN 2026-07-31 00840097534244 Kinos Aeros Total Ankle Replacement Restor3d, Inc. HSN 2026-07-31 00840097534251 Kinos Aeros Total Ankle Replacement Restor3d, Inc. HSN 2026-07-31 00840097534268 Kinos Aeros Total Ankle Replacement Restor3d, Inc. HSN 2026-07-31 00840097534275 Kinos Aeros Total Ankle Replacement Restor3d, Inc. HSN 2026-07-31 00840097534282 Kinos Aeros Total Ankle Replacement Restor3d, Inc. HSN 2026-07-31 00889797111089 PROPHECY INCOMPASS WRIGHT MEDICAL TECHNOLOGY, INC. HSN 2026-06-23 00889797111096 PROPHECY INCOMPASS WRIGHT MEDICAL TECHNOLOGY, INC. HSN 2026-06-23 00889797111102 PROPHECY INCOMPASS WRIGHT MEDICAL TECHNOLOGY, INC. HSN 2026-06-23 00889797111119 PROPHECY INCOMPASS WRIGHT MEDICAL TECHNOLOGY, INC. HSN 2026-06-23 00889797111126 PROPHECY INCOMPASS WRIGHT MEDICAL TECHNOLOGY, INC. HSN 2026-06-23 00889797114837 PROPHECY INCOMPASS WRIGHT MEDICAL TECHNOLOGY, INC. HSN 2026-06-23 B095401122 Hintermann Series H2 Dt Medtech, LLC HSN 2018-03-21 B095402112 Hintermann Series H2 Dt Medtech, LLC HSN 2018-03-21 B095402113 Hintermann Series H2 Dt Medtech, LLC HSN 2018-03-21 B095402114 Hintermann Series H2 Dt Medtech, LLC HSN 2018-03-21 B095402121 Hintermann Series H2 Dt Medtech, LLC HSN 2018-03-21 B095402122 Hintermann Series H2 Dt Medtech, LLC HSN 2018-03-21 B095402123 Hintermann Series H2 Dt Medtech, LLC HSN 2018-03-21 B095402124 Hintermann Series H2 Dt Medtech, LLC HSN 2018-03-21 B095402125 Hintermann Series H2 Dt Medtech, LLC HSN 2018-03-21 B095322305 Hintermann Series H2 Dt Medtech, LLC HSN 2018-03-20 B095322306 Hintermann Series H2 Dt Medtech, LLC HSN 2018-03-20 B095322307 Hintermann Series H2 Dt Medtech, LLC HSN 2018-03-20 B095322315 Hintermann Series H2 Dt Medtech, LLC HSN 2018-03-20 B095322316 Hintermann Series H2 Dt Medtech, LLC HSN 2018-03-20 B095322317 Hintermann Series H2 Dt Medtech, LLC HSN 2018-03-20 B095322325 Hintermann Series H2 Dt Medtech, LLC HSN 2018-03-20 B095322326 Hintermann Series H2 Dt Medtech, LLC HSN 2018-03-20 B095322327 Hintermann Series H2 Dt Medtech, LLC HSN 2018-03-20