Scopis GmbH

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

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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

Ear, Nose, And Throat Stereotaxic Instrument (PGW) (10)

Premarket Exempt

Clear

Instrument clamp 2-6 mm - B057U1017010 Catalog Number : U1 017 01

Device Description : The Instrument clamp 2-6 mm is part of a clamp set that provides mounting of ins

Device Class : 2

Duns Number: 341702266

Premarket Exempt : No

Product Code : PGW

Prescription Use : Yes

Device Count : 1

Instrument clamp forceps - B057U1017020 Catalog Number : U1 017 02

Device Description : The Instrument clamp forceps is part of a clamp set that provides mounting of in

Device Class : 2

Duns Number: 341702266

Premarket Exempt : No

Product Code : PGW

Prescription Use : Yes

Device Count : 1

Instrument clamp 6-10 mm - B057U1017030 Catalog Number : U1 017 03

Device Description : The Instrument clamp 6-10 mm is part of a clamp set that provides mounting of in

Device Class : 2

Duns Number: 341702266

Premarket Exempt : No

Product Code : PGW

Prescription Use : Yes

Device Count : 1

Instrument clamp 10-16 mm - B057U1017050 Catalog Number : U1 017 05

Device Description : The Instrument clamp 10-16 mm is part of a clamp set that provides mounting of i

Device Class : 2

Duns Number: 341702266

Premarket Exempt : No

Product Code : PGW

Prescription Use : Yes

Device Count : 1

Precision Pointer EM - B057U1029010 Catalog Number : U1 029 01

Device Description : The Precision Pointer EM is an electromagnetically tracked instrument that is us

Device Class : 2

Duns Number: 341702266

Premarket Exempt : No

Product Code : PGW

Prescription Use : Yes

Device Count : 1

Registration pointer EM-D - B057U1029030 Catalog Number : U1 029 03

Device Description : The Registration Pointer EM-D is an electromagnetically tracked instrument with

Device Class : 2

Duns Number: 341702266

Premarket Exempt : No

Product Code : PGW

Prescription Use : Yes

Device Count : 1

Suction tube Frazier EM - B057U1030110 Catalog Number : U1 030 11

Device Description : The Suction tube Frazier EM provides an electromagnetically tracked instrument t

Device Class : 2

Duns Number: 341702266

Premarket Exempt : No

Product Code : PGW

Prescription Use : Yes

Device Count : 1

Suction tube Eicken EM - B057U1030120 Catalog Number : U1 030 12

Device Description : The Suction tube Eicken EM provides an electromagnetically tracked instrument th

Device Class : 2

Duns Number: 341702266

Premarket Exempt : No

Product Code : PGW

Prescription Use : Yes

Device Count : 1

Patient tracker EM mini - B057U1031120 Catalog Number : U1 031 12

Device Description : The Patient Tracker EM mini provides a reference point on the patient. This refe

Device Class : 2

Duns Number: 341702266

Premarket Exempt : No

Product Code : PGW

Prescription Use : Yes

Device Count : 1

Patient tracker EM-D mini - B057U1031300 Catalog Number : U1 031 30

Device Description : The Patient Tracker EM-D mini provides a reference point on the patient. This re

Device Class : 2

Duns Number: 341702266

Premarket Exempt : No

Product Code : PGW

Prescription Use : Yes

Device Count : 1

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