Hummingbird® Cranial Access Kit

Basic Information

• Brand Name: Hummingbird® Cranial Access Kit
• Primary DI: 00850013266197
• Version / Model: IC42
• Catalog Number: IC42
• Company Name: IRRAS USA
• Labeler DUNS: 056999617
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-01-29
• Public Version: 1
• Public Version Date: 2020-02-06
• Public Version Status: New
• Public Device Record Key: 61e24e69-8682-41a2-95e2-c03f0a5a7667

Device Description

IC42 Cranial Access Kit

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: Yes
• Sterilization Methods: Ethylene Oxide

GMDN Terms

Code	Name	Definition	Implantable	Status
61401	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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10850013266194	GS1	Box	1	In Commercial Distribution
Primary	00850013266197	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 15 – 30 Degrees Celsius
• Type: Handling Environment Temperature
• Temperature Range: 15 – 30 Degrees Celsius