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

Endoscopic Access Overtube, Gastroenterology-Urology (FED) (6) Kit, Nephroscope (FGA) (6) Obturator, For Endoscope (FEC) (6) Cystoscope And Accessories, Flexible/Rigid (FAJ) (3) Hysteroscope (And Accessories) (HIH) (3) Led Light Source (NTN) (1)

Premarket Exempt

No Yes

Clear

NA - 04250480103173 Catalog Number :

Device Description : Hysteroscope/Cystoscope 4 x 283 mm, 30°

Device Class : 2

Duns Number: 316276682

Premarket Exempt : No

Product Code : FAJ, HIH

Prescription Use : Yes

Device Count : 1

NA - 04250480103180 Catalog Number :

Device Description : Hysteroscope/Cystoscope 4 x 283 mm, 30°

Device Class : 2

Duns Number: 316276682

Premarket Exempt : No

Product Code : HIH, FAJ

Prescription Use : Yes

Device Count : 1

NA - 04250480103197 Catalog Number :

Device Description : Hysteroscope/Cystoscope 4 x 283 mm, 70°

Device Class : 2

Duns Number: 316276682

Premarket Exempt : No

Product Code : FAJ, HIH

Prescription Use : Yes

Device Count : 1

N/A - 04250480105641 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 - 04250480106051 Catalog Number :

Device Description : UMP Ultra-Mini Nephroscope 1 x 260 mm, 0°

Device Class : 2

Duns Number: 316276682

Premarket Exempt : No

Product Code : FGA, FEC, FED

Prescription Use : Yes

Device Count : 1

NA - 04250480106068 Catalog Number :

Device Description : UMP - 6 Fr., inner sheath, WL: 220 mm

Device Class : 2

Duns Number: 316276682

Premarket Exempt : No

Product Code : FGA, FEC, FED

Prescription Use : Yes

Device Count : 1

NA - 04250480106075 Catalog Number :

Device Description : UMP - 7.5 Fr., inner sheath, WL: 220 mm

Device Class : 2

Duns Number: 316276682

Premarket Exempt : No

Product Code : FGA, FEC, FED

Prescription Use : Yes

Device Count : 1

NA - 04250480106082 Catalog Number :

Device Description : UMP - Water jet sheath, 11 Fr., WL: 150 mm

Device Class : 2

Duns Number: 316276682

Premarket Exempt : No

Product Code : FGA, FEC, FED

Prescription Use : Yes

Device Count : 1

NA - 04250480106099 Catalog Number :

Device Description : UMP - Obturator for water jet sheath, 11 Fr., WL: 150 mm

Device Class : 2

Duns Number: 316276682

Premarket Exempt : No

Product Code : FGA, FEC, FED

Prescription Use : Yes

Device Count : 1

NA - 04250480106105 Catalog Number :

Device Description : UMP - Water jet sheath, 13 Fr., WL: 150 mm

Device Class : 2

Duns Number: 316276682

Premarket Exempt : No

Product Code : FGA, FEC, FED

Prescription Use : Yes

Device Count : 1

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