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

Cystoscope And Accessories, Flexible/Rigid (FAJ) (6) Hysteroscope (And Accessories) (HIH) (6) Ureteroscope And Accessories, Flexible/Rigid (FGB) (4)

Premarket Exempt

No Yes

Clear

NA - 04250480102985 Catalog Number :

Device Description : Uretero-Renoscope 7.5 Fr. x 310 mm, Working channel 5 Fr.

Device Class : 2

Duns Number: 316276682

Premarket Exempt : No

Product Code : FGB

Prescription Use : Yes

Device Count : 1

NA - 04250480103012 Catalog Number :

Device Description : Uretero-Renoscope 6 Fr. x 425 mm, Working channel 4 Fr.

Device Class : 2

Duns Number: 316276682

Premarket Exempt : No

Product Code : FGB

Prescription Use : Yes

Device Count : 1

NA - 04250480103029 Catalog Number :

Device Description : Uretero-Renoscope 6 Fr. x 310 mm, Working channel 4 Fr.

Device Class : 2

Duns Number: 316276682

Premarket Exempt : No

Product Code : FGB

Prescription Use : Yes

Device Count : 1

NA - 04250480103036 Catalog Number :

Device Description : Instrument bridge for Uretero-Renoscope

Device Class : 2

Duns Number: 316276682

Premarket Exempt : No

Product Code : FGB

Prescription Use : Yes

Device Count : 1

NA - 04250480103111 Catalog Number :

Device Description : Hysteroscope/Cystoscope 4 x 298 mm, 5°

Device Class : 2

Duns Number: 316276682

Premarket Exempt : No

Product Code : HIH, FAJ

Prescription Use : Yes

Device Count : 1

NA - 04250480103128 Catalog Number :

Device Description : Hysteroscope/Cystoscope 4 x 298 mm, 0°

Device Class : 2

Duns Number: 316276682

Premarket Exempt : No

Product Code : FAJ, HIH

Prescription Use : Yes

Device Count : 1

NA - 04250480103135 Catalog Number :

Device Description : Hysteroscope/Cystoscope 4 x 300 mm, 25°

Device Class : 2

Duns Number: 316276682

Premarket Exempt : No

Product Code : HIH, FAJ

Prescription Use : Yes

Device Count : 1

NA - 04250480103142 Catalog Number :

Device Description : Hysteroscope/Cystoscope 4 x 303 mm, 70°

Device Class : 2

Duns Number: 316276682

Premarket Exempt : No

Product Code : FAJ, HIH

Prescription Use : Yes

Device Count : 1

NA - 04250480103159 Catalog Number :

Device Description : Hysteroscope/Cystoscope 4 x 280 mm, 0°

Device Class : 2

Duns Number: 316276682

Premarket Exempt : No

Product Code : HIH, FAJ

Prescription Use : Yes

Device Count : 1

NA - 04250480103166 Catalog Number :

Device Description : Hysteroscope/Cystoscope 4 x 280 mm, 12°

Device Class : 2

Duns Number: 316276682

Premarket Exempt : No

Product Code : FAJ, HIH

Prescription Use : Yes

Device Count : 1

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