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
OTC false
Sterile false
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 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 HCT/P false Kit false Combination product false Lot or batch true Serial number false Manufacturing date on label false 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# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 08936214221363 Denture, Surgical guide 136 2022-10-17 08936214229987 Denture, Restoration Surgical guide 998 2023-02-20 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 08936214223008 Denture, Restoration 300 2022-10-17 08936214223022 Denture, Restoration 302 2022-10-17
Other Devices Sharing Product Codes#