Home GUDID 08936214220069 Surgical Guide
Primary DI 08936214220069
Brand Surgical Guide
Company ACESO DENTAL LABORATORY COMPANY LIMITED
Model 006
Device description Endosseous dental implant accessories.
Published 2022-10-03
Public version status Update
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 NDP Accessories, Implant, Dental, Endosseous
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class NDP Accessories, Implant, Dental, Endosseous Dental 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 08936214220069 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 08936214220069 08936214220069 8936214220069
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 673251143 Device count 1 DM exempt true Premarket exempt true Lot or batch true Sterilization required before use true Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 08936214221028 Restoration 102 2022-10-12 08936214221066 Restoration 106 2022-10-12 08936214221080 Denture, Restoration 108 2022-10-12 08936214221103 Denture, Restoration 110 2022-10-12 08936214221127 Denture, Restoration 112 2022-10-12 08936214221141 Restoration 114 2022-10-12 08936214221165 Restoration 116 2022-10-12 08936214221189 Denture, Restoration 118 2022-10-13 08936214221202 Denture, Restoration 120 2022-10-13 08936214221226 Denture, Restoration 122 2022-10-13 08936214221240 Restoration 124 2022-10-17 08936214221264 Denture, Restoration 126 2022-10-17 08936214221288 Restoration 128 2022-10-17 08936214221301 Restoration 130 2022-10-17 08936214221325 Denture, Restoration 132 2022-10-17 08936214221349 Restoration 134 2022-10-17 08936214221363 Denture, Surgical guide 136 2022-10-17 08936214223008 Denture, Restoration 300 2022-10-17 08936214223022 Denture, Restoration 302 2022-10-17 08936214223046 Restoration 304 2022-10-17
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