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
OTC false
Sterile false
Single use false 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 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 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 false 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 00889795150080 APEX 3D Total Ankle Replacement System Paragon 28, Inc. HSN 2026-10-12 00889795150097 APEX 3D Total Ankle Replacement System Paragon 28, Inc. HSN 2026-10-12 00889795150103 APEX 3D Total Ankle Replacement System Paragon 28, Inc. HSN 2026-10-12 00889795150110 APEX 3D Total Ankle Replacement System Paragon 28, Inc. HSN 2026-10-12 00889795150127 APEX 3D Total Ankle Replacement System Paragon 28, Inc. HSN 2026-10-12 00889795150134 APEX 3D Total Ankle Replacement System Paragon 28, Inc. HSN 2026-10-12 00889795151001 APEX 3D Total Ankle Replacement System Paragon 28, Inc. HSN 2026-10-12 00889795151018 APEX 3D Total Ankle Replacement System Paragon 28, Inc. HSN 2026-10-12 00889795151025 APEX 3D Total Ankle Replacement System Paragon 28, Inc. HSN 2026-10-12 00889795151032 APEX 3D Total Ankle Replacement System Paragon 28, Inc. HSN 2026-10-12 00889795151049 APEX 3D Total Ankle Replacement System Paragon 28, Inc. HSN 2026-10-12 00889795151056 APEX 3D Total Ankle Replacement System Paragon 28, Inc. HSN 2026-10-12 00889795151063 APEX 3D Total Ankle Replacement System Paragon 28, Inc. HSN 2026-10-12 00889795151070 APEX 3D Total Ankle Replacement System Paragon 28, Inc. HSN 2026-10-12 00889795151087 APEX 3D Total Ankle Replacement System Paragon 28, Inc. HSN 2026-10-12 00889795151094 APEX 3D Total Ankle Replacement System Paragon 28, Inc. HSN 2026-10-12 00889795151100 APEX 3D Total Ankle Replacement System Paragon 28, Inc. HSN 2026-10-12 00889795151117 APEX 3D Total Ankle Replacement System Paragon 28, Inc. HSN 2026-10-12 00889795151124 APEX 3D Total Ankle Replacement System Paragon 28, Inc. HSN 2026-10-12 00889795151131 APEX 3D Total Ankle Replacement System Paragon 28, Inc. HSN 2026-10-12 00889795151148 APEX 3D Total Ankle Replacement System Paragon 28, Inc. HSN 2026-10-12 00889795151155 APEX 3D Total Ankle Replacement System Paragon 28, Inc. HSN 2026-10-12 00889795151162 APEX 3D Total Ankle Replacement System Paragon 28, Inc. HSN 2026-10-12 00889795151179 APEX 3D Total Ankle Replacement System Paragon 28, Inc. HSN 2026-10-12 00889795151186 APEX 3D Total Ankle Replacement System Paragon 28, Inc. HSN 2026-10-12 00889795151193 APEX 3D Total Ankle Replacement System Paragon 28, Inc. HSN 2026-10-12 00889795151209 APEX 3D Total Ankle Replacement System Paragon 28, Inc. HSN 2026-10-12 00889795151216 APEX 3D Total Ankle Replacement System Paragon 28, Inc. HSN 2026-10-12 00889795151223 APEX 3D Total Ankle Replacement System Paragon 28, Inc. HSN 2026-10-12 00889795151230 APEX 3D Total Ankle Replacement System Paragon 28, Inc. HSN 2026-10-12
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