Home GUDID 10850013266248 Hummingbird
Primary DI 10850013266248
Brand Hummingbird
Company IRRAS USA
Model CK 42
Device description IC42 Cranial Access Kit
Published 2023-10-13
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 10850013266248 Package GS1 6 In Commercial Distribution 00850013266241 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 10850013266248 10850013266248 00850013266241 00850013266241 850013266241 0850013266241
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.
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 true Sterilization required before use false Other Devices From This Company#