Home GUDID H980045001410 NA
Primary DI H980045001410
Brand NA
Company SYNTHES (U.S.A.) LP
Model 04.500.141
Catalog number 04500141
Device description 2.0MM CURVILINEAR DISTRACTOR R40/LEFT
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 10887587016764 Primary GS1 0 H980045001410 Secondary HIBCC 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized table Source identifier GTIN-14 normalized 10887587016764 10887587016764
GMDN Terms# Term, Definition table Term Definition Implantable craniofacial bone distractor An implantable or partially-implantable device intended to temporarily distract (force apart) the two bone surfaces of the mandible (the lower jawbone) or maxilla (the upper jawbone) during craniomaxillofacial (CMF) distraction. It functions as a single-patient bone lengthening/augmentation device for the correction of congenital deficiencies or post-traumatic defects when gradual bone augmentation is required. It typically consists of a metal tube in which a right- and left-hand threaded rod rotates and to which are attached two craniofacial fixation plates that are surgically screwed to either side of the fracture. A small tip guard may be included to protect against inadvertent rotation.
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 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 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 00888118105561 DISTRACTION, INTERNAL, STERILE KLS-Martin L.P. MQN 2016-12-16 10888118104066 DISTRACTION, INTERNAL, STERILE KLS-Martin L.P. MQN 2016-12-16 10888118104073 DISTRACTION, INTERNAL, STERILE KLS-Martin L.P. MQN 2016-12-16 10888118104080 DISTRACTION, INTERNAL, STERILE KLS-Martin L.P. MQN 2016-12-16 10888118104097 DISTRACTION, INTERNAL, STERILE KLS-Martin L.P. MQN 2016-12-16 10888118104103 DISTRACTION, INTERNAL, STERILE KLS-Martin L.P. MQN 2016-12-16 10888118104110 DISTRACTION, INTERNAL, STERILE KLS-Martin L.P. MQN 2016-12-16 00888118006189 LEVEL ONE CMF KLS-Martin L.P. MQN 2016-03-24 00888118006202 LEVEL ONE CMF KLS-Martin L.P. MQN 2016-03-24 00888118006226 LEVEL ONE CMF KLS-Martin L.P. MQN 2016-03-24 00888118007261 LEVEL ONE CMF KLS-Martin L.P. MQN 2016-03-24 00888118007278 LEVEL ONE CMF KLS-Martin L.P. MQN 2016-03-24 00888118032812 LEVEL ONE CMF KLS-Martin L.P. MQN 2016-03-24 00888118037480 LEVEL ONE CMF KLS-Martin L.P. MQN 2016-03-24
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