SUNOPTIC TECHNOLOGIES LLC

SUNOPTIC TECHNOLOGIES LLC

Address:6018 BOWDENDALE AVE.,JACKSONVILLE,FL,32216,US

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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

Light Source, Fiberoptic, Routine (FCW) (3) Headlight, Fiberoptic Focusing (FCT) (2) Light, Surgical, Fiberoptic (FST) (2) Camera, Television, Endoscopic, Without Audio (FWF) (1) Illuminator, Fiberoptic, Surgical Field (HBI) (1) Retractor (GAD) (1)

Premarket Exempt

No Yes

Clear

Sunoptic Technologies - M678CS0 Catalog Number :

Device Description : camera systems

Device Class : 1

Duns Number: 094586898

Premarket Exempt : Yes

Product Code : FWF

Prescription Use : Yes

Device Count : 1

Sunoptic Technologies - M678DLS0 Catalog Number :

Device Description : LED Rover Disoposable Series

Device Class : 2

Duns Number: 094586898

Premarket Exempt : Yes

Product Code : FCW

Prescription Use : Yes

Device Count : 1

Sunoptic Surgical, CUDA, Sunoptic Technologies, OEM Customer - M678DPLS300W0 Catalog Number :

Device Description : Xenon Lightsource, 300 Watt, Digital

Device Class : 2

Duns Number: 094586898

Premarket Exempt : Yes

Product Code : HBI

Prescription Use : Yes

Device Count : 1

Sunoptic Technologies - M678FOC0 Catalog Number :

Device Description : fiberoptic cables

Device Class : 2

Duns Number: 094586898

Premarket Exempt : No

Product Code : FST

Prescription Use : Yes

Device Count : 1

Sunoptic Technologies - M678HAL0 Catalog Number :

Device Description : Halogen lightsources

Device Class : 2

Duns Number: 094586898

Premarket Exempt : No

Product Code : FCW

Prescription Use : Yes

Device Count : 1

TRACLUX - M678HHR0 Catalog Number :

Device Description : Hand Held Retractor and accessories

Device Class : 1

Duns Number: 094586898

Premarket Exempt : Yes

Product Code : GAD

Prescription Use : Yes

Device Count : 1

Sunoptic Technologies - M678HL0 Catalog Number :

Device Description : headlights

Device Class : 2

Duns Number: 094586898

Premarket Exempt : Yes

Product Code : FCT

Prescription Use : Yes

Device Count : 1

Sunoptic Technologies - M678HLC0 Catalog Number :

Device Description : Fiberoptic Cables for headlight

Device Class : 2

Duns Number: 094586898

Premarket Exempt : No

Product Code : FST

Prescription Use : Yes

Device Count : 1

Sunoptic Technologies - M678HLM0 Catalog Number :

Device Description : headlights molded

Device Class : 2

Duns Number: 094586898

Premarket Exempt : Yes

Product Code : FCT

Prescription Use : Yes

Device Count : 1

Sunoptic Technologies - M678LED30000 Catalog Number :

Device Description : LED3000 lightsource

Device Class : 2

Duns Number: 094586898

Premarket Exempt : Yes

Product Code : FCW

Prescription Use : Yes

Device Count : 1

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