Home GUDID B238H000036010
QFlow 500 Titanium Bolt-Single Lumen
Primary DI B238H000036010
Brand QFlow 500 Titanium Bolt-Single Lumen
Company HEMEDEX, INC
Model NA
Catalog number H0000-3601
Device description Intracranial Single Lumen Bolt
Published 2016-09-21
Public version status Update
Distribution status In Commercial Distribution
MRI safety MR Unsafe
Rx true
Sterile true
Single use true Product Codes# Code, Name table Code Name GWM Device, Monitoring, Intracranial Pressure
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class GWM Device, Monitoring, Intracranial Pressure Neurology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status B238H000036010 Primary HIBCC 0
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.
Sterilization Methods# Method table Method Ethylene Oxide
Regulatory Flags# DUNS number 128045676 Device count 1 Lot or batch true Manufacturing date on label true Expiration date on label true Sterilization required before use true Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published B238H000036110 QFlow 500 2.7mm Drill Bit Kit NA H0000-3611 2016-09-21 B238H000036120 QFlow 500 5.3mm Drill Bit Kit NA H0000-3612 2016-09-21 B238H000007100 Bowman Perfusion Monitor, 120V Model 500 H0000-0710 2016-09-21 B238H000016000 QFlow 500 Perfusion Probe NA H0000-1600 2016-09-21 B238H000036020 QFlow 500 Titanium Bolt-Dual Lumen NA H0000-3602 2016-09-21 B238H000036310 QFlow 500 Titanium Bolt-Single Lumen Bolt Kit NA H0000-3631 2016-09-21 B238H000036320 QFlow 500 Titanium Bolt-Dual Lumen Bolt Kit NA H0000-3632 2016-09-21 B238H000036420 QFlow 500 Titanium Bolt-Dual Lumen Bolt Kit with Introducer NA H0000-3642 2016-09-21 B238H000036440 QFlow 500 Titanium Bolt-Quad Lumen Bolt Kit NA H0000-3644 2016-09-21 B238H000036810 QFlow 500 Bolt Accessory Kit NA H0000-3681 2016-09-23 B238H000036830 QFlow 500 Probe Dura Piercer and Introducer Kit NA H0000-3683 2016-09-21 B238H000036840 QFlow 500 Quad Lumen Cranial Bolt Large-Lumen Introducer NA H0000-3684 2016-09-21 B238H000036850 QFlow 500 Male-Female Luer Coupler NA H0000-3685 2016-09-21 B238H000107110 Bowman Perfusion Monitor, 240V Model 500 H0001-0711 2016-09-21
Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 07908398200008 Braincare BRAINCARE DESENVOLVIMENTO E INOVACAO TECNOLOGICA SA GWM 2026-05-08 00850013266272 IRRAflow Cranial Access Bolt Clearpoint Neuro, Inc. GWM 2025-07-24 00763000281243 Exacta Pole Clamp with laser level MEDTRONIC PS MEDICAL, INC. GWM 2025-02-17 00763000281229 Exacta Pole Clamp with laser level MEDTRONIC PS MEDICAL, INC. GWM 2025-02-16 00763000467401 NA MEDTRONIC PS MEDICAL, INC. GWM 2024-06-01 00763000406073 Becker MEDTRONIC PS MEDICAL, INC. GWM 2024-03-31 20763000467344 NA MEDTRONIC PS MEDICAL, INC. GWM 2024-03-01 20763000467351 NA MEDTRONIC PS MEDICAL, INC. GWM 2024-02-26 20763000467382 NA MEDTRONIC PS MEDICAL, INC. GWM 2024-02-26 20763000467399 NA MEDTRONIC PS MEDICAL, INC. GWM 2024-02-26 00763000406080 NA MEDTRONIC PS MEDICAL, INC. GWM 2024-02-26 00763000431259 Becker MEDTRONIC PS MEDICAL, INC. GWM 2024-02-26 00763000529307 Becker MEDTRONIC PS MEDICAL, INC. GWM 2024-02-26 00763000529369 Becker MEDTRONIC PS MEDICAL, INC. GWM 2024-02-26 00763000572877 Becker MEDTRONIC PS MEDICAL, INC. GWM 2024-02-25 00850013266203 IRRAflow Tube Set Clearpoint Neuro, Inc. GWM 2023-11-02 00763000624774 Duet® MEDTRONIC PS MEDICAL, INC. GWM 2022-03-10 00763000624781 Duet® MEDTRONIC PS MEDICAL, INC. GWM 2022-03-10 00763000624798 Duet® MEDTRONIC PS MEDICAL, INC. GWM 2022-03-10 00763000428723 Duet® MEDTRONIC PS MEDICAL, INC. GWM 2021-03-07 00763000428747 Duet® MEDTRONIC PS MEDICAL, INC. GWM 2021-03-07 00763000428754 Duet® MEDTRONIC PS MEDICAL, INC. GWM 2021-03-07 00763000428761 Duet® MEDTRONIC PS MEDICAL, INC. GWM 2021-03-07 00763000428778 Duet® MEDTRONIC PS MEDICAL, INC. GWM 2021-03-07 00763000431273 Duet® MEDTRONIC PS MEDICAL, INC. GWM 2021-02-13 20763000431307 N/A MEDTRONIC PS MEDICAL, INC. GWM 2021-02-07 00763000395971 Duet® MEDTRONIC PS MEDICAL, INC. GWM 2021-02-07 00763000395988 N/A MEDTRONIC PS MEDICAL, INC. GWM 2021-02-07 00763000406004 Duet® MEDTRONIC PS MEDICAL, INC. GWM 2021-02-07 00763000406011 Duet® MEDTRONIC PS MEDICAL, INC. GWM 2021-02-07