Home GUDID EFIAE0030010 Adhesive Pad
Primary DI EFIAE0030010
Brand Adhesive Pad
Company Intersect ENT GmbH
Model 1
Catalog number E 00 3001
Published 2022-01-21
Public version status New
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 PGW Ear, Nose, And Throat Stereotaxic Instrument
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class PGW Ear, Nose, And Throat Stereotaxic Instrument Neurology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status EFIAE0030011 Primary HIBCC 0 04260759931512 Secondary GS1 0 EFIAE0030010 Unit of Use HIBCC 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 04260759931512 04260759931512 4260759931512
GMDN Terms# Term, Definition table Term Definition Multi-purpose stereotactic surgery system An assembly of devices that typically consists of a rigid frame, positioning and alignment components, workstation, and a calibrated guide mechanism for precisely positioning probes, other instruments, or implantable devices during a surgical procedure of more than one discipline [e.g., orthopaedic and ear/nose/throat (ENT)]. The system may include computerized functions to store diagnostic images used for image-guided surgery.
Device Sizes# Type, Value, Unit table Type Value Unit Device Size Text, specify 0 Weight 0.036 Kilogram
Storage And Handling# Type, Low, High table Type Low High Condition Handling Environment Atmospheric Pressure 70 KiloPascal 106 KiloPascal Handling Environment Humidity 30 Percent (%) Relative Humidity 75 Percent (%) Relative Humidity Handling Environment Temperature 10 Degrees Celsius 27 Degrees Celsius
Regulatory Flags# DUNS number 312623008 Device count 10 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 false Other Devices Sharing Product Codes# 
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