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
Intracerebral cannula nonimplantable reusableIntracerebral cannula nonimplantable reusableClass III
Neurological stereotactic surgery systemNeurological stereotactic surgery systemClass III
Neurosurgical procedure kit non-medicated single-useNeurosurgical procedure kit non-medicated single-useClass IIa
Neurophysiologic monitoring systemNeurophysiologic monitoring systemClass IIa
Medical device cleaning sponge/setMedical device cleaning sponge/set
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
Intracerebral cannula nonimplantable single-useIntracerebral cannula nonimplantable single-useClass I
Intracerebral cannula nonimplantable single-useIntracerebral cannula nonimplantable single-useClass I
Intracerebral cannula nonimplantable single-useIntracerebral cannula nonimplantable single-useClass I
Intracerebral cannula nonimplantable single-useIntracerebral cannula nonimplantable single-useClass I
Intracerebral cannula nonimplantable single-useIntracerebral cannula nonimplantable single-useClass IIa
Intracerebral cannula nonimplantable single-useIntracerebral cannula nonimplantable single-useClass III