BLACKROCK MICROSYSTEMS, LLC

Address:630 S Komas Dr Ste 200,Salt Lake City,UT,84108,US

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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

Electrode, Depth (GZL) (10) Amplifier, Physiological Signal (GWL) (1)

Premarket Exempt

Clear

NeuroPort Electrode - 00814901020001 Catalog Number : 4382

Device Description : NeuroPort Electrode 1.0mm

Device Class : 2

Duns Number: 827132015

Premarket Exempt : No

Product Code : GZL, GWL

Prescription Use : Yes

Device Count : 1

NeuroPort Electrode - 00814901020018 Catalog Number : 4383

Device Description : NeuroPort Electrode 1.5mm

Device Class : 2

Duns Number: 827132015

Premarket Exempt : No

Product Code : GZL

Prescription Use : Yes

Device Count : 1

NeuroPort Electrode (SIROF) - 00814901020025 Catalog Number : 6248

Device Description : NeuroPort Electrode (SIROF) 1.5mm

Device Class : 2

Duns Number: 827132015

Premarket Exempt : No

Product Code : GZL

Prescription Use : Yes

Device Count : 1

NeuroPort Electrode (SIROF) - 00814901020032 Catalog Number : 6249

Device Description : NeuroPort Electrode (SIROF) 1.0mm

Device Class : 2

Duns Number: 827132015

Premarket Exempt : No

Product Code : GZL

Prescription Use : Yes

Device Count : 1

NeuroPort Inserter Assembly - 00814901020049 Catalog Number : 4523

Device Description : Inserter Pneumatic Control Box

Device Class : 2

Duns Number: 827132015

Premarket Exempt : No

Product Code : GZL

Prescription Use : Yes

Device Count : 1

NeuroPort Inserter Assembly - 00814901020056 Catalog Number : 4468

Device Description : Inserter Wand and Trigger Assembly 1.0mm

Device Class : 2

Duns Number: 827132015

Premarket Exempt : No

Product Code : GZL

Prescription Use : Yes

Device Count : 1

NeuroPort Inserter Assembly - 00814901020063 Catalog Number : 4469

Device Description : Inserter Wand and Trigger Assembly 1.5mm

Device Class : 2

Duns Number: 827132015

Premarket Exempt : No

Product Code : GZL

Prescription Use : Yes

Device Count : 1

NeuroPort Inserter Assembly - 00814901020070 Catalog Number : 4273

Device Description : Inserter Wand Holder

Device Class : 2

Duns Number: 827132015

Premarket Exempt : No

Product Code : GZL

Prescription Use : Yes

Device Count : 1

NeuroPort Inserter Assembly - 00814901020087 Catalog Number : 4484

Device Description : Head Holder Adapter

Device Class : 2

Duns Number: 827132015

Premarket Exempt : No

Product Code : GZL

Prescription Use : Yes

Device Count : 1

NeuroPort Array Assembly - 00814901020094 Catalog Number : 4312

Device Description : Pedestal Cap

Device Class : 2

Duns Number: 827132015

Premarket Exempt : No

Product Code : GZL

Prescription Use : Yes

Device Count : 1

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