Home GUDID 00888118105431 DISTRACTION, INTERNAL, STERILE
Primary DI 00888118105431
Brand DISTRACTION, INTERNAL, STERILE
Company KLS-Martin L.P.
Model 51-604-50-71
Device description DIST, CRANIO MANDIBLE FIXATOR, W/WEDGE, 18 MM STEP, 2.7 MM PIN, 2.0-2.3 MM SCREW, TI-6AL-4V
Published 2016-12-16
Public version status Update
Distribution status Not in Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
OTC false
Sterile true
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 00888118105431 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 00888118105431 00888118105431 888118105431 0888118105431
GMDN Terms# Term, Definition table Term Definition Implantable craniofacial bone distractor A non-powered 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. 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.
Device Sizes# Type, Value, Unit table Type Value Unit Device Size Text, specify 0
Regulatory Flags# DUNS number 826499238 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 true Donation ID number false Contains natural rubber latex false No natural rubber latex false Sterilization required before use false Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 00888118150288 LEVEL ONE CMF, STERILE 50-280-00-71 2026-10-21 00888118150295 LEVEL ONE CMF, STERILE 50-280-03-71 2026-10-21 00888118150301 LEVEL ONE CMF, STERILE 50-280-05-71 2026-10-21 00888118150318 LEVEL ONE CMF, STERILE 50-280-07-71 2026-10-21 00888118150325 LEVEL ONE CMF, STERILE 50-280-09-71 2026-10-21 00888118150332 LEVEL ONE CMF, STERILE 50-280-11-71 2026-10-21 00888118150349 LEVEL ONE CMF, STERILE 50-282-00-71 2026-10-21 00888118150356 LEVEL ONE CMF, STERILE 50-282-03-71 2026-10-21 00888118150363 LEVEL ONE CMF, STERILE 50-282-05-71 2026-10-21 00888118150370 LEVEL ONE CMF, STERILE 50-282-07-71 2026-10-21 00888118150387 LEVEL ONE CMF, STERILE 50-282-09-71 2026-10-21 00888118150394 LEVEL ONE CMF, STERILE 50-282-11-71 2026-10-21 00888118150400 LEVEL ONE CMF, STERILE 50-302-09-71 2026-10-21 00888118150417 LEVEL ONE CMF, STERILE 50-302-11-71 2026-10-21 00888118154910 LEVEL ONE CMF 25-874-11-61 2026-10-21 00888118154927 LEVEL ONE CMF 25-874-11-91 2026-10-21 00888118154934 LEVEL ONE CMF 25-874-15-91 2026-10-21 00888118154941 LEVEL ONE CMF 25-874-15-61 2026-10-21 00888118154958 LEVEL ONE CMF, STERILE 25-874-11-71 2026-10-21 00888118154965 LEVEL ONE CMF, STERILE 25-874-15-71 2026-10-21
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 00888118105554 DISTRACTION, INTERNAL, STERILE KLS-Martin L.P. MQN 2016-12-16 00888118105561 DISTRACTION, INTERNAL, STERILE KLS-Martin L.P. MQN 2016-12-16
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