BIOSENSE WEBSTER (ISRAEL) LTD.

Address:4 Hatnufa Street,Yokneam Northern,IL

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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

Ear, Nose, and Throat Stereotaxic Instrument (PGW) (2) COMPUTER, DIAGNOSTIC, PROGRAMMABLE (DQK) (1) Computer, diagnostic, programmable (DQK) (1)

Premarket Exempt

Clear

CARTO 3 - 10846835000870 Catalog Number : FG-5400-00

Device Description : CARTO 3

Device Class : 2

Duns Number: 514556950

Premarket Exempt : No

Product Code : DQK

Prescription Use : No

Device Count : 1

NOGA XP - 10846835011678 Catalog Number : FG170000

Device Description : NOGA XP-Cardiac Mapping System

Device Class : 2

Duns Number: 514556950

Premarket Exempt : No

Product Code : DQK

Prescription Use : No

Device Count : 1

Carto ENT - 10846835017182 Catalog Number : FG-2000-00

Device Description : ACCLARENT® ENT Navigation System

Device Class : 2

Duns Number: 514556950

Premarket Exempt : No

Product Code : PGW

Prescription Use : No

Device Count : 1

TruDi™ Navigation System - 10846835018639 Catalog Number : FG-2000-00

Device Description : TruDi™ Navigation System

Device Class : 2

Duns Number: 514556950

Premarket Exempt : No

Product Code : PGW

Prescription Use : No

Device Count : 1

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