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

Otoscope (ERA) (4) Camera, Television, Endoscopic, Without Audio (FWF) (1) Endoscopic Access Overtube, Gastroenterology-Urology (FED) (1) Kit, Nephroscope (FGA) (1) Laryngoscope, Rigid (CCW) (1) Obturator, For Endoscope (FEC) (1) Source, Carrier, Fiberoptic Light (EQH) (1) Accessories, Cleaning Brushes, For Endoscope (MNL) (1) Speculum, Ent (EPY) (1)

Premarket Exempt

No Yes

Clear

NA - 04250480106938 Catalog Number :

Device Description : UMP - Cleaning basket

Device Class : 2

Duns Number: 316276682

Premarket Exempt : No

Product Code : FGA, FEC, FED

Prescription Use : Yes

Device Count : 1

NA - 04250480106945 Catalog Number :

Device Description : UMP - Set of cleaning brushes (4 pieces)

Device Class : 1

Duns Number: 316276682

Premarket Exempt : Yes

Product Code : MNL

Prescription Use : Yes

Device Count : 1

NA - 04250480106976 Catalog Number :

Device Description : Light Guide 3.5 x 2300 mm, HT version

Device Class : 1

Duns Number: 316276682

Premarket Exempt : Yes

Product Code : EQH

Prescription Use : Yes

Device Count : 1

NA - 04250480107027 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

PrimeSight - 04250480107300 Catalog Number :

Device Description : Otoscope 4 x 50 mm, 30°

Device Class : 1

Duns Number: 316276682

Premarket Exempt : Yes

Product Code : ERA

Prescription Use : Yes

Device Count : 1

PrimeSight - 04250480107317 Catalog Number :

Device Description : Otoscope 4 x 50 mm, 0°

Device Class : 1

Duns Number: 316276682

Premarket Exempt : Yes

Product Code : ERA

Prescription Use : Yes

Device Count : 1

PrimeSight - 04250480107324 Catalog Number :

Device Description : Otoscope 2.7 x 34 mm, 0°

Device Class : 1

Duns Number: 316276682

Premarket Exempt : Yes

Product Code : ERA

Prescription Use : Yes

Device Count : 1

PrimeSight - 04250480107331 Catalog Number :

Device Description : Otoscope 2.7 x 34 mm, 0°

Device Class : 1

Duns Number: 316276682

Premarket Exempt : Yes

Product Code : ERA

Prescription Use : Yes

Device Count : 1

PrimeSight - 04250480107348 Catalog Number :

Device Description : Ear speculum

Device Class : 1

Duns Number: 316276682

Premarket Exempt : Yes

Product Code : EPY

Prescription Use : Yes

Device Count : 1

PrimeSight - 04250480107355 Catalog Number :

Device Description : Laryngoscope 10 x 186 mm, 90°

Device Class : 1

Duns Number: 316276682

Premarket Exempt : Yes

Product Code : CCW

Prescription Use : Yes

Device Count : 1

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