Home GUDID 00888118127761 DISTRACTION, INTERNAL
Primary DI 00888118127761
Brand DISTRACTION, INTERNAL
Company KLS-Martin L.P.
Model 51-360-40-09
Device description DIST, LEFORT 1, ZURICH TELE, LEFT, 40 MM POSTERIOR BAR, 2.0-2.3 MM SCREW, TI-6AL-4V
Published 2020-07-22
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx 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 00888118127761 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 00888118127761 00888118127761 888118127761 0888118127761
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.
Device Sizes# Type, Value, Unit table Type Value Unit Device Size Text, specify 0
Sterilization Methods# Method table Method Moist Heat or Steam Sterilization
Regulatory Flags# DUNS number 826499238 Device count 1 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 00888118108357 DISTRACTION, INTERNAL, STERILE 51-556-20-81 2018-09-26 00888118108364 DISTRACTION, INTERNAL, STERILE 51-557-20-81 2018-09-26 00888118147226 LEVEL ONE EXTREMITY 26-950-64-04 2026-07-21 00888118147233 LEVEL ONE EXTREMITY 26-950-65-04 2026-07-21 00888118147240 LEVEL ONE EXTREMITY 26-950-66-04 2026-07-21 00888118147257 LEVEL ONE EXTREMITY 26-950-67-04 2026-07-21 00888118147264 LEVEL ONE EXTREMITY 26-950-68-04 2026-07-21 00888118147271 LEVEL ONE EXTREMITY 26-950-69-04 2026-07-21 00888118147714 LEVEL ONE EXTREMITY 26-950-58-04 2026-07-21 00888118147721 LEVEL ONE EXTREMITY 26-950-59-04 2026-07-21 00888118147738 LEVEL ONE EXTREMITY 26-950-62-04 2026-07-21 00888118147745 LEVEL ONE EXTREMITY 26-950-63-04 2026-07-21 00888118154620 LEVEL ONE CMF 25-315-92-91 2026-07-21 00888118154637 LEVEL ONE CMF 50-743-06-09 2026-07-21 00888118154644 LEVEL ONE, STERILE 25-433-97-71 2026-07-21 00888118154651 LEVEL ONE, STERILE 25-438-97-71 2026-07-21 00888118154668 LEVEL ONE, STERILE 25-439-91-71 2026-07-21 00888118154675 LEVEL ONE, STERILE 25-486-97-71 2026-07-21 00888118154682 LEVEL ONE, STERILE 25-487-97-71 2026-07-21 00888118154699 LEVEL ONE, STERILE 50-817-15-71 2026-07-21
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