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) (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 The Instrument clamp 2-6 mm is part of a clamp set that provides mounting of instrument trackers to conventional instruments. To track the location of compatible surgical instruments an instrument clamp with appropriate diameter is fixed to a rigid portion of the instrument and equipped with a Universal tracker EM.Instrument clamps are provided non-sterile and are intended to be sterilized by the user.Instrument clamps are reusable.

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 The Instrument clamp forceps is part of a clamp set that provides mounting of instrument trackers to conventional instruments. To track the location of compatible surgical instruments an instrument clamp with appropriate diameter is fixed to a rigid portion of the instrument and equipped with a Universal tracker EM.Instrument clamps are provided non-sterile and are intended to be sterilized by the user.Instrument clamps are reusable.

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 The Instrument clamp 6-10 mm is part of a clamp set that provides mounting of instrument trackers to conventional instruments. To track the location of compatible surgical instruments an instrument clamp with appropriate diameter is fixed to a rigid portion of the instrument and equipped with a Universal tracker EM.Instrument clamps are provided non-sterile and are intended to be sterilized by the user.Instrument clamps are reusable.

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 The Instrument clamp 10-16 mm is part of a clamp set that provides mounting of instrument trackers to conventional instruments. To track the location of compatible surgical instruments an instrument clamp with appropriate diameter is fixed to a rigid portion of the instrument and equipped with a Universal tracker EM.Instrument clamps are provided non-sterile and are intended to be sterilized by the user.Instrument clamps are reusable.

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 The Precision Pointer EM is an electromagnetically tracked instrument that is used to register the patient anatomy and to navigate within the anatomical space. The location of the instrument is referenced relative to a patient tracker that is attached to the patient. The pointer connects to the Hybrid Navigation Unit EM via an integrated cable.The Precision Pointer EM is provided non-sterile and is intended to be sterilized by the user. The Precision Pointer EM is reusable.

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 The Registration Pointer EM-D is an electromagnetically tracked instrument with a rounded, blunt tip that is used to register the patient anatomy. The location of the instrument is referenced relative to a patient tracker affixed to the patient’s anatomy. The pointer connects to the Hybrid Navigation Unit EM via an integrated cable.The Precision Pointer EM-D is provided non-sterile and is intended intended for high-level disinfection only. It is intended to be used prior to surgical draping while the patient environment is not covered under sterile drape. The Registration Pointer EM-D is reusable.

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 The Suction tube Frazier EM provides an electromagnetically tracked instrument that is used to navigate within the patient anatomy during surgery. The location of the instrument is referenced relative to a patient tracker that is affixed to the patient’s anatomy. The navigated suction tube connects to the Hybrid Navigation Unit EM via integrated cables.Suction tubes are provided non-sterile and is intended to be sterilized by the user.Suction tubes are reusable.

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 The Suction tube Eicken EM provides an electromagnetically tracked instrument that is used to navigate within the patient anatomy during surgery. The location of the instrument is referenced relative to a patient tracker that is affixed to the patient’s anatomy. The navigated suction tube connects to the Hybrid Navigation Unit EM via integrated cables.Suction tubes are provided non-sterile and are intended to be sterilized by the user.Suction tubes are reusable.

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 The Patient Tracker EM mini provides a reference point on the patient. This reference defines the patient location and is used to correlate the patient anatomy to the image set. The Patient Tracker connects to the Navigation Unit via an integrated cable.The Patient Tracker EM mini is provided non-sterile and is intended to be sterilized by the user.The Patient Tracker EM mini is reusable.

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 The Patient Tracker EM-D mini provides a reference point on the patient. This reference defines the patient location and is used to correlate the patient anatomy to the image set. The Patient Tracker connects to the Navigation Unit via an integrated cable.The Patient Tracker EM-D mini is provided non-sterile and is intended for high-level disinfection only.The Patient Tracker EM-D mini is reusable.

Device Class : 2

Duns Number: 341702266

Premarket Exempt : No

Product Code : PGW

Prescription Use : Yes

Device Count : 1

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