Scopis GmbH

Address:Heinrich-Heine-Platz 10,Berlin,DE

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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

Ear, Nose, And Throat Stereotaxic Instrument (PGW) (3)

Premarket Exempt

Clear

NOVA AR - B057U4003260170 Catalog Number : U4 003

Device Description : The Navigation Software NOVA AR provides import of image sets, building the imag The Navigation Software NOVA AR provides import of image sets, building the image-based model of patient anatomy, planning of target structures for surgical procedures, and displaying the location of navigated instruments relative to the model of the anatomy.

Device Class : 2

Duns Number: 341702266

Premarket Exempt : No

Product Code : PGW

Prescription Use : Yes

Device Count : 1

NOVA Basic - B057U40140 Catalog Number : U4 014

Device Description : The Navigation Software NOVA Basic provides import of image sets, building the i The Navigation Software NOVA Basic provides import of image sets, building the image-based model of patient anatomy, planning of surgical procedures, and displaying the location of navigated instruments relative to the model of the anatomy.

Device Class : 2

Duns Number: 341702266

Premarket Exempt : No

Product Code : PGW

Prescription Use : Yes

Device Count : 1

Patient tracker tabs (PU 100) - B057U9020010 Catalog Number : U9 020 01

Device Description : Patient tracker tabs are circular, medical grade, double-sided adhesive tape. Th Patient tracker tabs are circular, medical grade, double-sided adhesive tape. They serve to attach the navigation references products Patient tracker EM mini or Patient tracker EM-D mini to the patient during surgery.

Device Class :

Duns Number: 341702266

Premarket Exempt : No

Product Code : PGW

Prescription Use : Yes

Device Count : 10

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