Manufacturer's Devices - FHC Inc

Address:




1201 Main Street



Bowdoin

Maine 04287

United States


Authorised Representative/ UK Responsible Person
Name: Emergo Consulting (UK) Limited
Address:

Compass House Vision Park Histon c/o Cr360 – UL International



Cambridge

CB24 9BZ

England United Kingdom




Code/Term Type
Depth electrodeDepth electrodeClass III
Depth electrodeDepth electrodeClass III
Intracerebral cannula nonimplantable single-useIntracerebral cannula nonimplantable single-useClass III
Intracerebral cannula nonimplantable reusableIntracerebral cannula nonimplantable reusableClass III
Neurological stereotactic surgery systemNeurological stereotactic surgery systemClass IIa
Neurological stereotactic surgery systemNeurological stereotactic surgery systemClass IIa
Neurological stereotactic surgery systemNeurological stereotactic surgery systemClass IIa
Neurosurgical procedure kit non-medicated single-useNeurosurgical procedure kit non-medicated single-use
Neurophysiologic monitoring systemNeurophysiologic monitoring systemClass I
Neurological stereotactic surgery systemNeurological stereotactic surgery systemClass I
Medical device cleaning sponge/setMedical device cleaning sponge/setClass I
Neurosurgical micro targeting driveNeurosurgical micro targeting driveClass I
Electrical-only medical device connection cable reusableElectrical-only medical device connection cable reusableClass I
Patient surgical drape single-usePatient surgical drape single-useClass I
Surgical instrument/implant rackSurgical instrument/implant rackClass I
Depth electrodeDepth electrodeClass I