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) (5) Laparoscope, General & Plastic Surgery (GCJ) (3) Cystoscope And Accessories, Flexible/Rigid (FAJ) (2) Endoscopic Video Imaging System/Component, Gastroenterology-Urology (FET) (2) Hysteroscope (And Accessories) (HIH) (2) Laparoscope, Gynecologic (And Accessories) (HET) (2)

Premarket Exempt

No Yes

Clear

UROLIFT ® - 04250480108734 Catalog Number :

Device Description : Optical Grasping Forceps, double action jaws, rigid, 20 Fr

Device Class : 2

Duns Number: 316276682

Premarket Exempt : No

Product Code : HIH, FAJ

Prescription Use : Yes

Device Count : 1

UROLIFT ® - 04250480108741 Catalog Number :

Device Description : Optical Scissors, double action jaws, rigid, 20 Fr

Device Class : 2

Duns Number: 316276682

Premarket Exempt : No

Product Code : HIH, FAJ

Prescription Use : Yes

Device Count : 1

NA - 04250480108772 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 - 04250480108789 Catalog Number :

Device Description : Communication Adapter

Device Class : 1

Duns Number: 316276682

Premarket Exempt : Yes

Product Code : FWF

Prescription Use : Yes

Device Count : 1

TipVision™ - 04250480108796 Catalog Number :

Device Description : TipVisionTM Videoscope 10x341mm 0° AC

Device Class : 2

Duns Number: 316276682

Premarket Exempt : No

Product Code : FET, HET, GCJ

Prescription Use : Yes

Device Count : 1

TipVision™ - 04250480108802 Catalog Number :

Device Description : TipVisionTM Videoscope 10x341mm 30° AC

Device Class : 2

Duns Number: 316276682

Premarket Exempt : No

Product Code : FET, HET, GCJ

Prescription Use : Yes

Device Count : 1

EleVision™ - 04250480108819 Catalog Number :

Device Description : EleVisionTM HD 2 CCU Image REC

Device Class : 1

Duns Number: 316276682

Premarket Exempt : Yes

Product Code : FWF

Prescription Use : Yes

Device Count : 1

EleVision™ - 04250480108826 Catalog Number :

Device Description : EleVisionTM HD 2 CCU Image and Video REC , Covidien

Device Class : 1

Duns Number: 316276682

Premarket Exempt : Yes

Product Code : FWF

Prescription Use : Yes

Device Count : 1

NA - 04250480109090 Catalog Number :

Device Description : Controller 4K UHD USB Image Video Capture

Device Class : 1

Duns Number: 316276682

Premarket Exempt : Yes

Product Code : FWF

Prescription Use : Yes

Device Count : 1

NA - 04250480109106 Catalog Number :

Device Description : Laparoscope 10 x 344 mm, 0°, UHD

Device Class : 2

Duns Number: 316276682

Premarket Exempt : No

Product Code : GCJ

Prescription Use : Yes

Device Count : 1

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