Home GUDID 00888118080585 DISTRACTION, INTERNAL
Primary DI 00888118080585
Brand DISTRACTION, INTERNAL
Company KLS-Martin L.P.
Model 51-400-05-09
Device description ALIGNMENT ROD, ZURICH 2
Published 2018-09-26
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true Product Codes# Code, Name table Code Name FZX Guide, surgical, instrument
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class FZX Guide, Surgical, Instrument General, Plastic Surgery 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00888118080585 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 00888118080585 00888118080585 888118080585 0888118080585
GMDN Terms# Term, Definition table Term Definition Craniofacial alignment rod A surgical instrument typically used in pairs to facilitate correct cranial orientation of craniofacial implants (e.g., fixation plates being attached to jaw bones) and other devices (e.g., craniofacial distractors) during their application in craniofacial surgery. It is typically designed as a long, thin, rigid rod made of high-grade stainless steel or titanium alloy with connectors at either end for attachment to the devices being aligned; it may have a knurled mid section (to provide better grip) onto which other instruments can be locked to assist the orientation procedure. This is a reusable device.
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 Premarket exempt true 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 00888118132529 LEVEL ONE EXTREMITY 26-627-12-91 2026-04-23 00888118036582 _LEVEL ONE CMF 25-043-16-09 2016-03-24 00888118048196 LEVEL ONE CMF 25-885-05-91 2016-03-24 00888118073471 LEVEL ONE CMF 50-173-01-09 2016-03-24 00888118073488 LEVEL ONE CMF 50-173-02-09 2016-03-24 00888118075581 DISTRACTION, INTERNAL 50-347-05-09 2016-03-24 00888118075604 DISTRACTION, INTERNAL 50-347-07-09 2016-03-24 00888118075611 DISTRACTION, INTERNAL 50-347-09-09 2016-03-24 00888118075635 DISTRACTION, INTERNAL 50-348-05-09 2016-03-24 00888118075659 DISTRACTION, INTERNAL 50-348-07-09 2016-03-24 00888118075666 DISTRACTION, INTERNAL 50-348-09-09 2016-03-24 00888118104007 DISTRACTION, INTERNAL, STERILE 50-347-05-71 2016-12-16 00888118104014 DISTRACTION, INTERNAL, STERILE 50-347-07-71 2016-12-16 00888118104021 DISTRACTION, INTERNAL, STERILE 50-347-09-71 2016-12-16 00888118104038 DISTRACTION, INTERNAL, STERILE 50-348-05-71 2016-12-16 00888118104045 DISTRACTION, INTERNAL, STERILE 50-348-07-71 2016-12-16 00888118104052 DISTRACTION, INTERNAL, STERILE 50-348-09-71 2016-12-16 00888118112682 LEVEL ONE CMF 25-885-05-61 2018-01-26 00888118113399 DISTRACTION, INTERNAL 50-347-05-61 2018-01-26 00888118113405 DISTRACTION, INTERNAL 50-347-07-61 2018-01-26
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