Home GUDID 00810111224697 TMC PSI Cut Guide System
Primary DI 00810111224697
Brand TMC PSI Cut Guide System
Company Treace Medical Concepts, Inc.
Model PSI-02-00385
Device description Cut Guide
Published 2025-05-22
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
Single use true Product Codes# Code, Name table Code Name PBF Orthopaedic Surgical Planning And Instrument Guides
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class PBF Orthopaedic Surgical Planning And Instrument Guides Orthopedic 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00810111224697 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 00810111224697 00810111224697 810111224697 0810111224697
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 054808082 Device count 1 Lot or batch true Expiration date on label true 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 07630345779939 NextAR Spine Platform Medacta International SA PBF 2023-07-24 07630345797063 NextAR Spine Platform Medacta International SA PBF 2023-07-24 07630345797070 NextAR Spine Platform Medacta International SA PBF 2023-07-24 07630345797087 NextAR Spine Platform Medacta International SA PBF 2023-07-24 G2710300240140 Intelliguides Mios Marketing, LLC PBF 2023-01-01 G2710310240150 Intelliguides Mios Marketing, LLC PBF 2023-01-01 G2710310240160 Intelliguides Mios Marketing, LLC PBF 2023-01-01 G2710310240180 Intelliguides Mios Marketing, LLC PBF 2023-01-01 G2710310240190 Intelliguides Mios Marketing, LLC PBF 2023-01-01 G2710310240200 Intelliguides Mios Marketing, LLC PBF 2023-01-01 G2710310240210 Intelliguides Mios Marketing, LLC PBF 2023-01-01 G2710310240220 Intelliguides Mios Marketing, LLC PBF 2023-01-01 G2710310240230 Intelliguides Mios Marketing, LLC PBF 2023-01-01 G2710310240240 Intelliguides Mios Marketing, LLC PBF 2023-01-01 G2710310240250 Intelliguides Mios Marketing, LLC PBF 2023-01-01 G2710310260150 Intelliguides Mios Marketing, LLC PBF 2023-01-01 G2710310260160 Intelliguides Mios Marketing, LLC PBF 2023-01-01 G2710310260170 Intelliguides Mios Marketing, LLC PBF 2023-01-01 G2710310260180 Intelliguides Mios Marketing, LLC PBF 2023-01-01 G2710310260190 Intelliguides Mios Marketing, LLC PBF 2023-01-01 G2710310260200 Intelliguides Mios Marketing, LLC PBF 2023-01-01 G2710310260210 Intelliguides Mios Marketing, LLC PBF 2023-01-01 G2710310260220 Intelliguides Mios Marketing, LLC PBF 2023-01-01 G2710310260230 Intelliguides Mios Marketing, LLC PBF 2023-01-01 G2710310260240 Intelliguides Mios Marketing, LLC PBF 2023-01-01 G2710310260250 Intelliguides Mios Marketing, LLC PBF 2023-01-01 G2710310280150 Intelliguides Mios Marketing, LLC PBF 2023-01-01 G2710310280160 Intelliguides Mios Marketing, LLC PBF 2023-01-01 G2710310280170 Intelliguides Mios Marketing, LLC PBF 2023-01-01 G2710310280180 Intelliguides Mios Marketing, LLC PBF 2023-01-01