Home GUDID 00850013266180 Hummingbird® Cranial Access Kit
Primary DI 00850013266180
Brand Hummingbird® Cranial Access Kit
Company Clearpoint Neuro, Inc.
Model IC42-D
Catalog number IC42-D
Device description IC42-D Cranial Access Kit (w/ Drugs)
Published 2020-01-29
Public version status Update
Distribution status Not in Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
Sterile true
Single use true Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 10850013266187 Package GS1 1 Not in Commercial Distribution 00850013266180 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 10850013266187 10850013266187 00850013266180 00850013266180 850013266180 0850013266180
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 119078557 Device count 1 Premarket exempt true Kit true Lot or batch true Expiration date on label true Sterilization required before use true Other Devices From This Company# 
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