QFlow 500 2.7mm Drill Bit Kit

Basic Information

• Brand Name: QFlow 500 2.7mm Drill Bit Kit
• Primary DI: B238H000036110
• Version / Model: NA
• Catalog Number: H0000-3611
• Company Name: HEMEDEX, INC
• Labeler DUNS: 128045676
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-21
• Public Version: 4
• Public Version Date: 2018-11-22
• Public Version Status: Update
• Public Device Record Key: f6a81c2a-edf3-4857-8b34-dda25a82f70f

Device Description

2.7mm Drill Bit Kit

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: MR Unsafe
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

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

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
HBG	Drills, Burrs, Trephines & Accessories (Manual)	Neurology	882.4300	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	B238H000036110	HIBCC

Premarket Submissions

Submission Number	Supplement Number
K141869	000