DRILL KIT CH9

Basic Information

• Brand Name: DRILL KIT CH9
• Primary DI: 04057834024722
• Version / Model: 091668-002
• Company Name: RAUMEDIC AG
• Labeler DUNS: 332785323
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-08-18
• Public Version: 3
• Public Version Date: 2018-11-22
• Public Version Status: Update
• Public Device Record Key: b47ca997-7822-4662-a7c2-1dc2e79c889c

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• 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: No
• 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: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
GWM	Device, Monitoring, Intracranial Pressure	Neurology	882.1620	2

GMDN Terms

Code	Name	Definition	Implantable	Status
61402	Intracerebral catheterization drill bit	A sterile drilling endpiece intended to be used for drilling the skull of a patient to facilitate the introduction and fixation of an intracerebral sensor/infusion/drainage catheter. It is intended to be attached to a manual or electric drilling device. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04057834024722	GS1

Customer Contacts

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