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, Cortical (GYC) (10)

Premarket Exempt

Clear

XactStrip - 00814901020681 Catalog Number : 027670

Device Description : XactStrip, 4 Contact, Platinum, 1x4, 10mm Spacing

Device Class : 2

Duns Number: 827132015

Premarket Exempt : No

Product Code : GYC

Prescription Use : Yes

Device Count : 1

XactStrip - 00814901020704 Catalog Number : 027671

Device Description : XactStrip, 6 Contact, Platinum, 1x6, 10mm Spacing

Device Class : 2

Duns Number: 827132015

Premarket Exempt : No

Product Code : GYC

Prescription Use : Yes

Device Count : 1

XactStrip - 00814901020728 Catalog Number : 027672

Device Description : XactStrip, 8 Contact, Platinum, 1x8, 10mm Spacing

Device Class : 2

Duns Number: 827132015

Premarket Exempt : No

Product Code : GYC

Prescription Use : Yes

Device Count : 1

XactStrip - 00814901020742 Catalog Number : 027673

Device Description : XactStrip, 10 Contact, Platinum, 1x10, 10mm Spacing

Device Class : 2

Duns Number: 827132015

Premarket Exempt : No

Product Code : GYC

Prescription Use : Yes

Device Count : 1

XactStrip - 00814901020766 Catalog Number : 028933

Device Description : XactStrip, 4 Contact, Platinum, Reinforcement, 1x4, 10mm Spacing

Device Class : 2

Duns Number: 827132015

Premarket Exempt : No

Product Code : GYC

Prescription Use : Yes

Device Count : 1

XactStrip - 00814901020780 Catalog Number : 028934

Device Description : XactStrip, 6 Contact, Platinum, Reinforcement, 1x6, 10mm Spacing

Device Class : 2

Duns Number: 827132015

Premarket Exempt : No

Product Code : GYC

Prescription Use : Yes

Device Count : 1

XactStrip - 00814901020803 Catalog Number : 028935

Device Description : XactStrip, 8 Contact, Platinum, Reinforcement, 1x8, 10mm Spacing

Device Class : 2

Duns Number: 827132015

Premarket Exempt : No

Product Code : GYC

Prescription Use : Yes

Device Count : 1

XactStrip - 00814901020827 Catalog Number : 028936

Device Description : XactStrip, 10 Contact, Platinum, Reinforcement, 1x10, 10mm Spacing

Device Class : 2

Duns Number: 827132015

Premarket Exempt : No

Product Code : GYC

Prescription Use : Yes

Device Count : 1

XactGrid - 00814901020841 Catalog Number : 027674

Device Description : XactGrid, 8 Contact, Platinum, 2x4, 1 Tail, 10mm Spacing

Device Class : 2

Duns Number: 827132015

Premarket Exempt : No

Product Code : GYC

Prescription Use : Yes

Device Count : 1

XactGrid - 00814901020865 Catalog Number : 027675

Device Description : XactGrid, 16 Contact, Platinum, 2x8, 1 Tail, 10mm Spacing

Device Class : 2

Duns Number: 827132015

Premarket Exempt : No

Product Code : GYC

Prescription Use : Yes

Device Count : 1

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