HEMEDEX, INC

Want to know more about this Organization? Request more information now!

Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Device, Monitoring, Intracranial Pressure (GWM) (6) Drills, Burrs, Trephines & Accessories (Manual) (HBG) (6) Flowmeter, Blood, Cardiovascular (DPW) (2)

Premarket Exempt

Clear

Bowman Perfusion Monitor, 120V - B238H000007100 Catalog Number : H0000-0710

Device Description : Perfusion Monitor, 120V

Device Class : 2

Duns Number: 128045676

Premarket Exempt : No

Product Code : DPW

Prescription Use : Yes

Device Count : 1

QFlow 500 Perfusion Probe - B238H000016000 Catalog Number : H0000-1600

Device Description : Thermal Diffusion Probe

Device Class : 2

Duns Number: 128045676

Premarket Exempt : No

Product Code : DPW

Prescription Use : Yes

Device Count : 1

QFlow 500 Titanium Bolt-Single Lumen - B238H000036010 Catalog Number : H0000-3601

Device Description : Intracranial Single Lumen Bolt

Device Class : 2

Duns Number: 128045676

Premarket Exempt : No

Product Code : GWM

Prescription Use : Yes

Device Count : 1

QFlow 500 Titanium Bolt-Dual Lumen - B238H000036020 Catalog Number : H0000-3602

Device Description : Intracranial dual lumen bolt

Device Class : 2

Duns Number: 128045676

Premarket Exempt : No

Product Code : GWM

Prescription Use : Yes

Device Count : 1

QFlow 500 2.7mm Drill Bit Kit - B238H000036110 Catalog Number : H0000-3611

Device Description : 2.7mm Drill Bit Kit

Device Class : 2

Duns Number: 128045676

Premarket Exempt : No

Product Code : HBG

Prescription Use : Yes

Device Count : 1

QFlow 500 5.3mm Drill Bit Kit - B238H000036120 Catalog Number : H0000-3612

Device Description : 5.3mm Drill Bit Kit

Device Class : 2

Duns Number: 128045676

Premarket Exempt : No

Product Code : HBG

Prescription Use : Yes

Device Count : 1

QFlow 500 Titanium Bolt-Single Lumen Bolt Kit - B238H000036310 Catalog Number : H0000-3631

Device Description : Intracranial Single Lumen Bolt Kit

Device Class : 2

Duns Number: 128045676

Premarket Exempt : No

Product Code : HBG, GWM

Prescription Use : Yes

Device Count : 1

QFlow 500 Titanium Bolt-Dual Lumen Bolt Kit - B238H000036320 Catalog Number : H0000-3632

Device Description : Intracranial Dual Lumen Bolt Kit

Device Class : 2

Duns Number: 128045676

Premarket Exempt : No

Product Code : HBG, GWM

Prescription Use : Yes

Device Count : 1

QFlow 500 Titanium Bolt-Dual Lumen Bolt Kit with Introducer - B238H000036420 Catalog Number : H0000-3642

Device Description : Intracranial Dual lumen bolt kit with introducer

Device Class : 2

Duns Number: 128045676

Premarket Exempt : No

Product Code : HBG, GWM

Prescription Use : Yes

Device Count : 1

QFlow 500 Titanium Bolt-Quad Lumen Bolt Kit - B238H000036440 Catalog Number : H0000-3644

Device Description : Intracranial Quad Lumen Bolt Kit

Device Class : 2

Duns Number: 128045676

Premarket Exempt : No

Product Code : HBG, GWM

Prescription Use : Yes

Device Count : 1

Previous 1 2 Next