SCHÖLLY FIBEROPTIC GmbH

Address:ROBERT-BOSCH-STR. 1-3,DENZLINGEN Baden-Wurttemberg,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

Camera, Television, Endoscopic, Without Audio (FWF) (1) Endoscopic Video Imaging System/Component, Gastroenterology-Urology (FET) (1) Laparoscope, General & Plastic Surgery (GCJ) (1) Led Light Source (NTN) (1)

Premarket Exempt

No Yes

Clear

NA - 04250480109113 Catalog Number :

Device Description : Laparoscope 10 x 344 mm, 30°, UHD

Device Class : 2

Duns Number: 316276682

Premarket Exempt : No

Product Code : GCJ

Prescription Use : Yes

Device Count : 1

EleVision™ - 04250480110287 Catalog Number :

Device Description : EleVision TM 4K Camera Control Unit

Device Class : 2

Duns Number: 316276682

Premarket Exempt : No

Product Code : FET

Prescription Use : Yes

Device Count : 1

EleVision™ - 04250480110294 Catalog Number :

Device Description : EleVision TM 4K Camera Head

Device Class : 1

Duns Number: 316276682

Premarket Exempt : Yes

Product Code : FWF

Prescription Use : Yes

Device Count : 1

EleVision™ - 04250480110300 Catalog Number :

Device Description : EleVision TM LED Light Source

Device Class : 2

Duns Number: 316276682

Premarket Exempt : Yes

Product Code : NTN

Prescription Use : Yes

Device Count : 1

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