Home GUDID 03701337614355 QUANTUM
Primary DI 03701337614355
Brand QUANTUM
Company IN2BONES
Model M05 PSI
Catalog number M05 PSI
Device description QUANTUM PSI GUIDES FOR TOTAL ANKLE REPLACEMENT, US
Published 2024-12-13
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx 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 03701337614355 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 03701337614355 03701337614355 3701337614355
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 263616749 Device count 1 Lot or batch true Manufacturing 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 10381780237730 Cadence™ Ascension Orthopedics, Inc. HSN 2016-01-12 10381780237747 Cadence™ Ascension Orthopedics, Inc. HSN 2016-01-12 10381780237754 Cadence™ Ascension Orthopedics, Inc. HSN 2016-01-12 10381780237761 Cadence™ Ascension Orthopedics, Inc. HSN 2016-01-12 10381780237778 Cadence™ Ascension Orthopedics, Inc. HSN 2016-01-12 10381780237785 Cadence™ Ascension Orthopedics, Inc. HSN 2016-01-12 10381780237792 Cadence™ Ascension Orthopedics, Inc. HSN 2016-01-12 10381780237808 Cadence™ Ascension Orthopedics, Inc. HSN 2016-01-12 10381780237815 Cadence™ Ascension Orthopedics, Inc. HSN 2016-01-12 10381780237822 Cadence™ Ascension Orthopedics, Inc. HSN 2016-01-12 10381780237839 Cadence™ Ascension Orthopedics, Inc. HSN 2016-01-12 10381780237846 Cadence™ Ascension Orthopedics, Inc. HSN 2016-01-12 10381780237853 Cadence™ Ascension Orthopedics, Inc. HSN 2016-01-12 10381780237860 Cadence™ Ascension Orthopedics, Inc. HSN 2016-01-12 10381780237877 Cadence™ Ascension Orthopedics, Inc. HSN 2016-01-12 10381780237884 Cadence™ Ascension Orthopedics, Inc. HSN 2016-01-12 10381780237891 Cadence™ Ascension Orthopedics, Inc. HSN 2016-01-12 10381780237907 Cadence™ Ascension Orthopedics, Inc. HSN 2016-01-12 10381780237914 Cadence™ Ascension Orthopedics, Inc. HSN 2016-01-12 10381780237921 Cadence™ Ascension Orthopedics, Inc. HSN 2016-01-12 10381780237938 Cadence™ Ascension Orthopedics, Inc. HSN 2016-01-12 10381780237945 Cadence™ Ascension Orthopedics, Inc. HSN 2016-01-12 10381780237952 Cadence™ Ascension Orthopedics, Inc. HSN 2016-01-12 10381780237969 Cadence™ Ascension Orthopedics, Inc. HSN 2016-01-12 10381780237976 Cadence™ Ascension Orthopedics, Inc. HSN 2016-01-12 10381780237983 Cadence™ Ascension Orthopedics, Inc. HSN 2016-01-12 10381780237990 Cadence™ Ascension Orthopedics, Inc. HSN 2016-01-12 10381780238003 Cadence™ Ascension Orthopedics, Inc. HSN 2016-01-12 10381780238010 Cadence™ Ascension Orthopedics, Inc. HSN 2016-01-12 10381780238027 Cadence™ Ascension Orthopedics, Inc. HSN 2016-01-12
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