Home GUDID 00886020028442 EMERGE MEDICAL & Design
Primary DI 00886020028442
Brand EMERGE MEDICAL & Design
Company EMERGE MEDICAL, INC.
Model 312.20.EM
Catalog number 312.20.EM
Device description 2.0MM PARALLEL DRILL GUIDE AND DRILL SLEEVE
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 00886020028442 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 00886020028442 00886020028442 886020028442 0886020028442
GMDN Terms# Term, Definition table Term Definition Surgical drill guide, reusable A hand-held tubular surgical device designed to simultaneously place, angle, and guide a rotating surgical drill on hard tissue (e.g., bone), and to protect the surrounding soft tissue while the drill is in operation. It may have serrations at its distal end to enable firm placement on hard tissue surfaces (it is not bored into the tissue); it can have a handle at its proximal end for holding and manipulation, or it may be held by another device (e.g., orthopaedic jig). The device is typically dedicated to drill bit size, made of metal, and may have graduations along its length; it is not custom-made for a specific patient. 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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