Home GUDID E0HM645431 OKTAGON®
Primary DI E0HM645431
Brand OKTAGON®
Company Hager & Meisinger Gesellschaft mit beschränkter Haftung
Model 64543
Catalog number 64543
Device description Manual instrument for dental/surgical application
Published 2021-09-15
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx 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 E0HM645431 Primary HIBCC 0
GMDN Terms# Term, Definition table Term Definition Surgical drill guide, reusable A manual surgical device designed to simultaneously place, angle, and guide a rotating surgical drill on hard tissue (e.g., bone); some types are also intended for guiding bone-coring instruments (e.g., keel punch). It is designed in a tubular form or with guiding holes and may have serrations at its distal end to enable firm placement on hard tissue surfaces (it is not bored into the tissue); it can have a handle or be held by another device (e.g., orthopaedic jig), and typically allows protection of the surrounding soft tissue during surgery. It is typically made of metal and may have graduations along its length; it is not custom-made for a specific patient. This is a reusable device.
Sterilization Methods# Method table Method Moist Heat or Steam Sterilization
Regulatory Flags# DUNS number 318034329 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 EDRS220011 OKTAGON Dental Implant BL RC 22001 22001 2015-10-01 EDRS220021 OKTAGON Dental Implant BL RC 22002 22002 2015-10-01 EDRS220031 OKTAGON Dental Implant BL RC 22003 22003 2015-10-01 EDRS220041 OKTAGON Dental Implant BL RC 22004 22004 2015-10-01 EDRS220051 OKTAGON Dental Implant BL RC 22005 22005 2015-10-01 EDRS220061 OKTAGON Dental Implant BL RC 22006 22006 2015-10-01 EDRS220071 OKTAGON Dental Implant BL RC 22007 22007 2015-10-01 EDRS220081 OKTAGON Dental Implant BL RC 22008 22008 2015-10-01 EDRS220091 OKTAGON Dental Implant BL NC 22009 22009 2015-10-01 EDRS220101 OKTAGON Dental Implant BL NC 22010 22010 2015-10-01 EDRS220111 OKTAGON Dental Implant BL NC 22011 22011 2015-10-01 EDRS220121 OKTAGON Dental Implant BL NC 22012 22012 2015-10-01 EDRS220131 OKTAGON BL NC Cover screw GH 0.0 mm 22013 22013 2017-01-27 EDRS220141 OKTAGON BL NC Cover screw GH 0.5 mm 22014 22014 2017-01-27 EDRS220171 OKTAGON BL NC Healing abutment, conical Ø3.6 mm GH 2.0 mm 22017 22017 2017-01-27 EDRS220181 OKTAGON BL NC Healing abutment, conical Ø3.6 mm GH 3.5 mm 22018 22018 2017-01-27 EDRS220191 OKTAGON BL NC Healing abutment, conical Ø3.6 mm GH 5.0 mm 22019 22019 2017-01-27 EDRS220201 OKTAGON BL NC Healing abutment, conical Ø4.8 mm GH 2.0 mm 22020 22020 2017-01-27 EDRS220211 OKTAGON BL NC Healing abutment, conical Ø4.8 mm GH 3.5 mm 22021 22021 2017-01-27 EDRS220221 OKTAGON BL NC Healing abutment, conical Ø4.8 mm GH 5.0 mm 22022 22022 2017-01-27
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