GENTUITY LLC

Address:142 North Road,Sudbury,MA,01776,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

System, Imaging, Optical Coherence Tomography (Oct) (NQQ) (2) Catheter, Intravascular, Diagnostic (DQO) (1)

Premarket Exempt

Clear

Vis-Rx - 00859910007018 Catalog Number :

Device Description : 1.8F Rapid exchange micro-imaging high frequency OCT catheter kit - US

Device Class : 2

Duns Number: 077509759

Premarket Exempt : No

Product Code : DQO

Prescription Use : Yes

Device Count : 1

Gentuity HF-OCT Imaging System - 00859910007032 Catalog Number :

Device Description : Gentuity OCT imaging console, including optical engine, PC, PIM with umbilical, Gentuity OCT imaging console, including optical engine, PC, PIM with umbilical, 2 monitors (one with touch screen) and keyboard/mouse.

Device Class : 2

Duns Number: 077509759

Premarket Exempt : No

Product Code : NQQ

Prescription Use : Yes

Device Count : 1

Gentuity - 00859910007049 Catalog Number : G80-01

Device Description : Gentuity Off-line Review Station includes computer, monitor, keyboard, and mouse.

Device Class : 2

Duns Number: 077509759

Premarket Exempt : No

Product Code : NQQ

Prescription Use : Yes

Device Count : 1

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