Manufacturer's Devices - Integra LifeSciences Production Corporation_Mansfield

Address:




11 Cabot Boulevard



Mansfield

MA 02048

United States


Authorised Representative/ UK Responsible Person
Name: Integra Neurosciences Limited
Address:

Kingsgate House Newbury Road



Andover

Hampshire SP10 4DU

England United Kingdom




Code/Term Type
Neurosurgical spongeNeurosurgical spongeClass III
Lumbar cerebrospinal fluid drainage catheterization kitLumbar cerebrospinal fluid drainage catheterization kit
Ventricular cerebrospinal fluid drainage catheterization kitVentricular cerebrospinal fluid drainage catheterization kit
Intracerebral catheter cranial-fixation kitIntracerebral catheter cranial-fixation kit
Cerebrospinal fluid shunt valveCerebrospinal fluid shunt valveClass IIb
Ventriculoperitoneal shuntVentriculoperitoneal shuntClass III
Subcutaneous tunneller single-useSubcutaneous tunneller single-useClass III
Cerebrospinal fluid shunt connectorCerebrospinal fluid shunt connectorClass III
Open-surgery electrosurgical handpiece/electrode bipolar reusableOpen-surgery electrosurgical handpiece/electrode bipolar reusableClass III
Dura mater biomatrix implantDura mater biomatrix implantClass III
Open-surgery electrosurgical handpiece/electrode bipolar single-useOpen-surgery electrosurgical handpiece/electrode bipolar single-useClass III
Epidural needle non-threadedEpidural needle non-threadedClass III
Peritoneal/atrial cerebrospinal fluid catheterPeritoneal/atrial cerebrospinal fluid catheterClass III
Cranial port/reservoirCranial port/reservoirClass III
Intracerebral infusion/drainage catheter short-termIntracerebral infusion/drainage catheter short-termClass III
Intracerebral trocar bladeIntracerebral trocar bladeClass III
Lumboperitoneal shuntLumboperitoneal shuntClass III
Intracerebral cannula nonimplantable reusableIntracerebral cannula nonimplantable reusableClass III
Intracranial pressure monitorIntracranial pressure monitorClass III
Fluted surgical drill bit reusableFluted surgical drill bit reusableClass III
Scalp haemostasis clip reusableScalp haemostasis clip reusableClass III
Scalp haemostasis clip single-useScalp haemostasis clip single-useClass IIa
Cranial trephine single-useCranial trephine single-useClass IIa
Automatic cranial perforator single-useAutomatic cranial perforator single-useClass IIa
Manual cranial rotary handpiece single-useManual cranial rotary handpiece single-useClass IIa
Craniotomy power tool system pneumaticCraniotomy power tool system pneumaticClass IIa
Scalp clip applier single-useScalp clip applier single-useClass IIa
Medium-wave diathermy treatment systemMedium-wave diathermy treatment systemClass IIa
Cerebrospinal fluid shunt valve programmerCerebrospinal fluid shunt valve programmerClass IIa
Surgical irrigation pumpSurgical irrigation pumpClass IIa
Electrosurgical system generatorElectrosurgical system generatorClass IIb
Intracranial/compartmental-pressure monitor calibrator/cableIntracranial/compartmental-pressure monitor calibrator/cableClass IIb
Cerebrospinal fluid external drainage kitCerebrospinal fluid external drainage kitClass IIb
Foot-switch electricalFoot-switch electricalClass IIa
Frame/rail/pole device holderFrame/rail/pole device holderClass IIa
Electrical-only medical device connection cable reusableElectrical-only medical device connection cable reusableClass IIb
Subcutaneous tunneller reusableSubcutaneous tunneller reusableClass IIb
Scalp clip forcepsScalp clip forcepsClass I
Electrical-only medical device connection cable single-useElectrical-only medical device connection cable single-useClass I
Atrial cerebrospinal fluid catheterCerebrospinal fluid shunt valve Conformity Assessment Certificate ExpiredClass I
Intracerebral infusion/drainage catheter long-termAtrial cerebrospinal fluid catheter Conformity Assessment Certificate ExpiredClass I
Intracerebral infusion/drainage catheter long-termIntracerebral infusion/drainage catheter long-term Conformity Assessment Certificate ExpiredClass I
Intracerebral infusion/drainage catheter long-termIntracerebral infusion/drainage catheter long-term Conformity Assessment Certificate ExpiredClass I
Intracerebral infusion/drainage catheter long-termIntracerebral infusion/drainage catheter long-term Conformity Assessment Certificate ExpiredClass I
Intracerebral infusion/drainage catheter long-termIntracerebral infusion/drainage catheter long-term Conformity Assessment Certificate ExpiredClass I
Intracerebral infusion/drainage catheter long-termIntracerebral infusion/drainage catheter long-term Conformity Assessment Certificate ExpiredClass I
Intracerebral infusion/drainage catheter long-termIntracerebral infusion/drainage catheter long-term Conformity Assessment Certificate ExpiredClass I
Intracerebral infusion/drainage catheter long-termIntracerebral infusion/drainage catheter long-term Conformity Assessment Certificate ExpiredClass I
Intracerebral infusion/drainage catheter long-termIntracerebral infusion/drainage catheter long-term Conformity Assessment Certificate ExpiredClass I
Intracerebral infusion/drainage catheter long-termIntracerebral infusion/drainage catheter long-term Conformity Assessment Certificate ExpiredClass III
Intracerebral infusion/drainage catheter long-termIntracerebral infusion/drainage catheter long-term Conformity Assessment Certificate ExpiredClass III
Intracerebral infusion/drainage catheter long-termIntracerebral infusion/drainage catheter long-term Conformity Assessment Certificate ExpiredClass III