Nuvera Medical, Inc.

Address:140 Knowles Dr,Los Gatos,CA,95032,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

Catheter, Ultrasound, Intravascular (OBJ) (2)

Premarket Exempt

Clear

NuVision ICE Catheter - 00860005688104 Catalog Number :

Device Description : The NUVISION™ ICE Catheter is a diagnostic ultrasound imaging catheter designed The NUVISION™ ICE Catheter is a diagnostic ultrasound imaging catheter designed for intracardiac use.

Device Class : 2

Duns Number: 117379819

Premarket Exempt : No

Product Code : OBJ

Prescription Use : Yes

Device Count : 1

NuVision Connector Cable - 00860005688111 Catalog Number :

Device Description : The NuVision Connector Cable is a non-sterile, reusable connector cable intended The NuVision Connector Cable is a non-sterile, reusable connector cable intended to connect the sterile, single-use NuVision ICE Catheter to a qualified GE ultrasound cardiac imaging system.

Device Class : 2

Duns Number: 117379819

Premarket Exempt : No

Product Code : OBJ

Prescription Use : No

Device Count : 1

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