Home GUDID 10850013266194 Hummingbird® Cranial Access Kit
Primary DI 10850013266194
Brand Hummingbird® Cranial Access Kit
Company IRRAS USA
Model IC42
Catalog number IC42
Device description IC42 Cranial Access Kit
Published 2020-01-29
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
OTC false
Sterile true
Single use true Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 10850013266194 Package GS1 1 In Commercial Distribution 00850013266197 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 10850013266194 10850013266194 00850013266197 00850013266197 850013266197 0850013266197
GMDN Terms# Term, Definition table Term Definition Intracerebral catheter cranial-fixation kit A collection of sterile devices intended to be used to affix an intracerebral sensor/infusion/drainage catheter on the skull of a patient. It includes cranial screws and screwing tools; it does not include the intracerebral catheter, and does not include devices intended for long-term implantation (> 30 days). This is a single-use device.
Storage And Handling# Type, Low, High table Type Low High Condition Handling Environment Temperature 15 Degrees Celsius 30 Degrees Celsius Storage Environment Temperature 15 Degrees Celsius 30 Degrees Celsius
Sterilization Methods# Method table Method Ethylene Oxide
Regulatory Flags# DUNS number 056999617 Device count 1 DM exempt false Premarket exempt true HCT/P false Kit true Combination product false Lot or batch true Serial number false Manufacturing date on label false Expiration date on label true Donation ID number false Contains natural rubber latex false No natural rubber latex false Sterilization required before use true Other Devices From This Company# 
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