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) (8) Laryngoscope, Rigid (CCW) (1) Led Light Source (NTN) (1)

Premarket Exempt

No Yes

Clear

PrimeSight - 04250480107362 Catalog Number :

Device Description : Laryngoscope 10 x 173 mm, 70°

Device Class : 1

Duns Number: 316276682

Premarket Exempt : Yes

Product Code : CCW

Prescription Use : Yes

Device Count : 1

NA - 04250480107423 Catalog Number :

Device Description : Camera Head Full HD Zoom

Device Class : 1

Duns Number: 316276682

Premarket Exempt : Yes

Product Code : FWF

Prescription Use : Yes

Device Count : 1

NA - 04250480107430 Catalog Number :

Device Description : Camera Head Full HD fix focal length

Device Class : 1

Duns Number: 316276682

Premarket Exempt : Yes

Product Code : FWF

Prescription Use : Yes

Device Count : 1

NA - 04250480107447 Catalog Number :

Device Description : Camera: Controller Full HD, Camera Head Full HD Zoom

Device Class : 1

Duns Number: 316276682

Premarket Exempt : Yes

Product Code : FWF

Prescription Use : Yes

Device Count : 1

NA - 04250480107584 Catalog Number :

Device Description : Camera Head Full HD 90° angled

Device Class : 1

Duns Number: 316276682

Premarket Exempt : Yes

Product Code : FWF

Prescription Use : Yes

Device Count : 1

NA - 04250480107614 Catalog Number :

Device Description : Controller Full HD

Device Class : 1

Duns Number: 316276682

Premarket Exempt : Yes

Product Code : FWF

Prescription Use : Yes

Device Count : 1

NA - 04250480107621 Catalog Number :

Device Description : Controller Full HD USB Image Capture

Device Class : 1

Duns Number: 316276682

Premarket Exempt : Yes

Product Code : FWF

Prescription Use : Yes

Device Count : 1

NA - 04250480107638 Catalog Number :

Device Description : Controller Full HD USB Image/Video Capture

Device Class : 1

Duns Number: 316276682

Premarket Exempt : Yes

Product Code : FWF

Prescription Use : Yes

Device Count : 1

N/A - 04250480107645 Catalog Number :

Device Description : LED Light Source

Device Class : 2

Duns Number: 316276682

Premarket Exempt : Yes

Product Code : NTN

Prescription Use : Yes

Device Count : 1

NA - 04250480107652 Catalog Number :

Device Description : Camera: Controller Full HD USB Image Capture, Camera head Full HD Zoom

Device Class : 1

Duns Number: 316276682

Premarket Exempt : Yes

Product Code : FWF

Prescription Use : Yes

Device Count : 1

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