FMD, LLC

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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, Cine, Endoscopic, Without Audio (FWL) (3) Light, Surgical, Fiberoptic (FST) (2) Led Light Source (NTN) (1)

Premarket Exempt

No Yes

Clear

DUROSCOPE - 00863333000303 Catalog Number : LC-0507-B

Device Description : Fiber optic Light guide

Device Class : 2

Duns Number: 124947339

Premarket Exempt : No

Product Code : FST

Prescription Use : Yes

Device Count : 1

DUROSCOPE - 00863333000310 Catalog Number : LD 2500

Device Description : LED Light source

Device Class : 2

Duns Number: 124947339

Premarket Exempt : Yes

Product Code : NTN

Prescription Use : No

Device Count : 1

DUROSCOPE - 00863333000327 Catalog Number : HD-101

Device Description : FHD Camera

Device Class : 1

Duns Number: 124947339

Premarket Exempt : Yes

Product Code : FWL

Prescription Use : No

Device Count : 1

DUROSCOPE - 00863333000334 Catalog Number : UHD-631

Device Description : UHD Camera

Device Class : 1

Duns Number: 124947339

Premarket Exempt : Yes

Product Code : FWL

Prescription Use : No

Device Count : 1

DUROSCOPE - 00863333000341 Catalog Number : LC-0507-C

Device Description : Fiber Optic Light Guide

Device Class : 2

Duns Number: 124947339

Premarket Exempt : No

Product Code : FST

Prescription Use : Yes

Device Count : 1

DUROSCOPE - 00863333000358 Catalog Number : CL 150

Device Description : Camera control and light source

Device Class : 1

Duns Number: 124947339

Premarket Exempt : Yes

Product Code : FWL

Prescription Use : No

Device Count : 1

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