Home GUDID 00886020028800 EMERGE MEDICAL & Design
Primary DI 00886020028800
Brand EMERGE MEDICAL & Design
Company EMERGE MEDICAL, INC.
Model 329.04.EM
Catalog number 329.04.EM
Device description BENDING IRON FOR 2.7MM & 3.5MM PLATES
Published 2015-07-08
Public version status Update
Distribution status Not in Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true Product Codes# Code, Name table Code Name LXH ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class LXH Orthopedic Manual Surgical Instrument Orthopedic 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00886020028800 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 00886020028800 00886020028800 886020028800 0886020028800
GMDN Terms# Term, Definition table Term Definition Orthopaedic fixation plate bending insert, reusable A device that is inserted into the threaded or non-threaded hole of a metal orthopaedic fixation plate (e.g., trauma or craniofacial plate) prior to the surgeon bending the plate to conform to the anatomical shape of the implant site (e.g., jawbone or pelvis) in order to preserve the integrity of the holes which would otherwise deform, negating the entry of the bone screws that hold the plate in place. It is typically made of metal or synthetic material in the form of a short screw or pin-like device with a slotted head (for the acceptance of a screwdriver) used solely during the bending of plates that typically have a continuous row of screw holes. This is a reusable device.
Sterilization Methods# Method table Method Moist Heat or Steam Sterilization
Regulatory Flags# DUNS number 078642955 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 00886020026417 EMERGE MEDICAL & Design 319.293.EM 319.293.EM 2015-07-08 00886020026431 EMERGE MEDICAL & Design 319.292.EM 319.292.EM 2015-07-08 00886020026455 EMERGE MEDICAL & Design 319.38.EM 319.38.EM 2015-07-08 00886020026479 EMERGE MEDICAL & Design 319.35.EM 319.35.EM 2015-07-08 00886020026554 EMERGE MEDICAL & Design 319.46.EM 319.46.EM 2015-07-08 00886020026899 EMERGE MEDICAL & Design 309.501.EM 309.501.EM 2015-07-08 00886020008109 EMERGE MEDICAL & Design 211.841.EM 211.841.EM 2015-07-07 00886020008116 EMERGE MEDICAL & Design 211.842.EM 211.842.EM 2015-07-07 00886020008123 EMERGE MEDICAL & Design 211.843.EM 211.843.EM 2015-07-07 00886020008130 EMERGE MEDICAL & Design 211.844.EM 211.844.EM 2015-07-07 00886020008147 EMERGE MEDICAL & Design 211.845.EM 211.845.EM 2015-07-07 00886020008154 EMERGE MEDICAL & Design 211.846.EM 211.846.EM 2015-07-07 00886020008161 EMERGE MEDICAL & Design 211.847.EM 211.847.EM 2015-07-07 00886020008178 EMERGE MEDICAL & Design 211.848.EM 211.848.EM 2015-07-07 00886020008185 EMERGE MEDICAL & Design 211.849.EM 211.849.EM 2015-07-07 00886020008284 EMERGE MEDICAL & Design 211.810.EM 211.810.EM 2015-07-07 00886020008291 EMERGE MEDICAL & Design 211.811.EM 211.811.EM 2015-07-07 00886020008307 EMERGE MEDICAL & Design 211.812.EM 211.812.EM 2015-07-07 00886020008314 EMERGE MEDICAL & Design 211.813.EM 211.813.EM 2015-07-07 00886020008321 EMERGE MEDICAL & Design 211.814.EM 211.814.EM 2015-07-07
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