Home GUDID H980043151080 NA
Primary DI H980043151080
Brand NA
Company SYNTHES (U.S.A.) LP
Model 04.315.108
Catalog number 04315108
Device description REMOVABLE EXTENSION ARM-RIGID 40MM FOR CMF DISTRACTOR
Published 2015-09-14
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 MQN EXTERNAL MANDIBULAR FIXATOR AND/OR DISTRACTOR
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class MQN External Mandibular Fixator And/Or Distractor Dental 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 10887587015644 Primary GS1 0 H980043151080 Secondary HIBCC 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized table Source identifier GTIN-14 normalized 10887587015644 10887587015644
GMDN Terms# Term, Definition table Term Definition Craniofacial bone distractor extension A partially-implantable device intended to be temporarily used as an extension for an implanted or partially-implanted craniofacial distractor allowing connection to the central adjustment thread of the distractor when its location is made difficult to access due to its surgical positioning. It is used to allow the required rotation of the thread in order to distract (force apart) the two bone surfaces of the mandibular body (the lower jawbone) during the adjustment period. It is typically made of high-grade stainless steel and may be rigid or flexible in design.
Sterilization Methods# Method table Method Moist Heat or Steam Sterilization
Regulatory Flags# DUNS number 832637081 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 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# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 00888118154910 LEVEL ONE CMF KLS-Martin L.P. MQN 2026-10-21 00888118154927 LEVEL ONE CMF KLS-Martin L.P. MQN 2026-10-21 00888118154934 LEVEL ONE CMF KLS-Martin L.P. MQN 2026-10-21 00888118154965 LEVEL ONE CMF, STERILE KLS-Martin L.P. MQN 2026-10-21 10888118154979 LEVEL ONE CMF KLS-Martin L.P. MQN 2026-10-21 10888118154986 LEVEL ONE CMF KLS-Martin L.P. MQN 2026-10-21 00888118128638 LEVEL ONE CMF KLS-Martin L.P. MQN 2020-08-24 00888118128645 LEVEL ONE CMF KLS-Martin L.P. MQN 2020-08-24 00888118128652 LEVEL ONE CMF KLS-Martin L.P. MQN 2020-08-24 00888118128669 LEVEL ONE CMF KLS-Martin L.P. MQN 2020-08-24 00888118128676 LEVEL ONE CMF KLS-Martin L.P. MQN 2020-08-24 00888118128683 LEVEL ONE CMF KLS-Martin L.P. MQN 2020-08-24 00888118112682 LEVEL ONE CMF KLS-Martin L.P. MQN 2018-01-26 00888118113399 DISTRACTION, INTERNAL KLS-Martin L.P. MQN 2018-01-26 00888118113405 DISTRACTION, INTERNAL KLS-Martin L.P. MQN 2018-01-26 00888118113412 DISTRACTION, INTERNAL KLS-Martin L.P. MQN 2018-01-26 00888118113429 DISTRACTION, INTERNAL KLS-Martin L.P. MQN 2018-01-26 00888118113436 DISTRACTION, INTERNAL KLS-Martin L.P. MQN 2018-01-26 00888118113443 DISTRACTION, INTERNAL KLS-Martin L.P. MQN 2018-01-26 00888118108685 LEVEL ONE CMF KLS-Martin L.P. MQN 2017-08-17 00888118107800 LEVEL ONE CMF KLS-Martin L.P. MQN 2017-03-31 00888118107817 LEVEL ONE CMF KLS-Martin L.P. MQN 2017-03-31 00888118104007 DISTRACTION, INTERNAL, STERILE KLS-Martin L.P. MQN 2016-12-16 00888118104014 DISTRACTION, INTERNAL, STERILE KLS-Martin L.P. MQN 2016-12-16 00888118104021 DISTRACTION, INTERNAL, STERILE KLS-Martin L.P. MQN 2016-12-16 00888118104038 DISTRACTION, INTERNAL, STERILE KLS-Martin L.P. MQN 2016-12-16 00888118104045 DISTRACTION, INTERNAL, STERILE KLS-Martin L.P. MQN 2016-12-16 00888118104052 DISTRACTION, INTERNAL, STERILE KLS-Martin L.P. MQN 2016-12-16 00888118105431 DISTRACTION, INTERNAL, STERILE KLS-Martin L.P. MQN 2016-12-16 00888118105554 DISTRACTION, INTERNAL, STERILE KLS-Martin L.P. MQN 2016-12-16
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