Home GUDID 10868643000484 Hummingbird® Cranial Access Kit
Primary DI 10868643000484
Brand Hummingbird® Cranial Access Kit
Company IRRAS USA
Model IC40D
Catalog number IC40-D
Device description IC40-D Cranial Access Kit (w/ Drugs)
Published 2019-10-10
Public version status Update
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 10868643000484 Package GS1 1 In Commercial Distribution 00868643000487 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 10868643000484 10868643000484 00868643000487 00868643000487 868643000487 0868643000487
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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