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) (4) Cystoscope And Accessories, Flexible/Rigid (FAJ) (4) Hysteroscope (And Accessories) (HIH) (2) Arthroscope (HRX) (1) Led Light Source (NTN) (1)

Premarket Exempt

No Yes

Clear

UROLIFT ® - 04250480107942 Catalog Number :

Device Description : Cystoscope 4 x 302 mm, 0°

Device Class : 2

Duns Number: 316276682

Premarket Exempt : No

Product Code : FAJ, HIH

Prescription Use : Yes

Device Count : 1

UROLIFT ® - 04250480107959 Catalog Number :

Device Description : Cystoscope 4 x 302 mm, 0°, Factory exchange

Device Class : 2

Duns Number: 316276682

Premarket Exempt : No

Product Code : FAJ, HIH

Prescription Use : Yes

Device Count : 1

NA - 04250480107980 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 - 04250480107997 Catalog Number :

Device Description : Camera Head Full HD autoclavable

Device Class : 1

Duns Number: 316276682

Premarket Exempt : Yes

Product Code : FWF

Prescription Use : Yes

Device Count : 1

NA - 04250480108000 Catalog Number :

Device Description : Camera Head 4K UHD Zoom

Device Class : 1

Duns Number: 316276682

Premarket Exempt : Yes

Product Code : FWF

Prescription Use : Yes

Device Count : 1

NA - 04250480108369 Catalog Number :

Device Description : Arthroscope 4 x 157 mm, 30°

Device Class : 2

Duns Number: 316276682

Premarket Exempt : No

Product Code : HRX

Prescription Use : Yes

Device Count : 1

BULKAMID ® - 04250480108529 Catalog Number :

Device Description : Cystoscope 2.7 mm x 113 mm, 0°

Device Class : 2

Duns Number: 316276682

Premarket Exempt : No

Product Code : FAJ

Prescription Use : Yes

Device Count : 1

BULKAMID ® - 04250480108581 Catalog Number :

Device Description : Cystoscope 2.7 mm x 113 mm, 0°, Factory Exchange

Device Class : 2

Duns Number: 316276682

Premarket Exempt : No

Product Code : FAJ

Prescription Use : Yes

Device Count : 1

NA - 04250480108703 Catalog Number :

Device Description : Camera Head Full HD 3CMOS Zoom

Device Class : 1

Duns Number: 316276682

Premarket Exempt : Yes

Product Code : FWF

Prescription Use : Yes

Device Count : 1

NA - 04250480108727 Catalog Number :

Device Description : Light Guide Adapter

Device Class : 2

Duns Number: 316276682

Premarket Exempt : Yes

Product Code : NTN

Prescription Use : Yes

Device Count : 1

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