Home GUDID 00888118083265 DISTRACTION, INTERNAL
Primary DI 00888118083265
Brand DISTRACTION, INTERNAL
Company KLS-Martin L.P.
Model 51-605-01-09
Device description PIVOT, MOLINA & ARNAUD-MARCHAC, FIG 1, TI-6AL-4V
Published 2016-03-24
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 JEY PLATE, BONE
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class JEY Plate, Bone Dental 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00888118083265 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 00888118083265 00888118083265 888118083265 0888118083265
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 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 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 00888118149671 LEVEL ONE CMF, STERILE KLS-Martin L.P. JEY 2026-03-23 00888118149701 LEVEL ONE CMF, STERILE KLS-Martin L.P. JEY 2026-03-23 00888118149718 LEVEL ONE CMF, STERILE KLS-Martin L.P. JEY 2026-03-23 00888118149725 LEVEL ONE CMF, STERILE KLS-Martin L.P. JEY 2026-03-23 00888118149732 LEVEL ONE CMF, STERILE KLS-Martin L.P. JEY 2026-03-23 00888118149749 LEVEL ONE CMF, STERILE KLS-Martin L.P. JEY 2026-03-23 00888118149756 LEVEL ONE CMF, STERILE KLS-Martin L.P. JEY 2026-03-23 00888118149763 LEVEL ONE CMF, STERILE KLS-Martin L.P. JEY 2026-03-23 00888118149770 LEVEL ONE CMF, STERILE KLS-Martin L.P. JEY 2026-03-23 00888118149787 LEVEL ONE CMF, STERILE KLS-Martin L.P. JEY 2026-03-23 00888118149794 LEVEL ONE CMF, STERILE KLS-Martin L.P. JEY 2026-03-23 00888118149800 LEVEL ONE CMF, STERILE KLS-Martin L.P. JEY 2026-03-23 00888118149817 LEVEL ONE CMF, STERILE KLS-Martin L.P. JEY 2026-03-23 00888118149824 LEVEL ONE CMF, STERILE KLS-Martin L.P. JEY 2026-03-23 00888118149831 LEVEL ONE CMF, STERILE KLS-Martin L.P. JEY 2026-03-23 00888118149848 LEVEL ONE CMF, STERILE KLS-Martin L.P. JEY 2026-03-23 00888118149855 LEVEL ONE CMF, STERILE KLS-Martin L.P. JEY 2026-03-23 00888118149879 LEVEL ONE CMF, STERILE KLS-Martin L.P. JEY 2026-03-23 00888118149886 LEVEL ONE CMF, STERILE KLS-Martin L.P. JEY 2026-03-23 00888118149893 LEVEL ONE CMF, STERILE KLS-Martin L.P. JEY 2026-03-23 00888118149909 LEVEL ONE CMF, STERILE KLS-Martin L.P. JEY 2026-03-23 00888118149916 LEVEL ONE CMF, STERILE KLS-Martin L.P. JEY 2026-03-23 00888118149923 LEVEL ONE CMF, STERILE KLS-Martin L.P. JEY 2026-03-23 00888118149930 LEVEL ONE CMF, STERILE KLS-Martin L.P. JEY 2026-03-23 00888118149947 LEVEL ONE CMF, STERILE KLS-Martin L.P. JEY 2026-03-23 00888118149954 LEVEL ONE CMF, STERILE KLS-Martin L.P. JEY 2026-03-23 00888118149961 LEVEL ONE CMF, STERILE KLS-Martin L.P. JEY 2026-03-23 00888118149978 LEVEL ONE CMF, STERILE KLS-Martin L.P. JEY 2026-03-23 00888118149985 LEVEL ONE CMF, STERILE KLS-Martin L.P. JEY 2026-03-23 00888118153128 LEVEL ONE NEURO, STERILE KLS-Martin L.P. JEY 2026-03-23
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