QFlow 500 Titanium Bolt-Dual Lumen Bolt Kit

Basic Information

• Brand Name: QFlow 500 Titanium Bolt-Dual Lumen Bolt Kit
• Primary DI: B238H000036320
• Version / Model: NA
• Catalog Number: H0000-3632
• 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: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: 1dac0e98-77f8-4aa2-bad0-448e5a52b3b5

Device Description

Intracranial Dual Lumen Bolt 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: 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
GWM	Device, Monitoring, Intracranial Pressure	Neurology	882.1620	2

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
Primary	B238H000036320	HIBCC

Premarket Submissions

Submission Number	Supplement Number
K141869	000