G.I. VIEW LTD

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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

Colonoscope And Accessories, Flexible/Rigid (FDF) (3)

Premarket Exempt

Clear

Aer-O-Scope Workstation - 07290016992007 Catalog Number : MASA0101

Device Description : The console unit for the Aer-O-Scope Colonoscope System

Device Class : 2

Duns Number: 533751681

Premarket Exempt : No

Product Code : FDF

Prescription Use : Yes

Device Count : 1

Aer-O-Scope Daily Tube Convenience Kit - 07290016992021 Catalog Number : MASA02502

Device Description : This KIT is comprised of the daily water tube and the daily suction tube

Device Class : 2

Duns Number: 533751681

Premarket Exempt : No

Product Code : FDF

Prescription Use : Yes

Device Count : 1

Aer-O-Scope Water Bottle - 07290016992038 Catalog Number : MASA02474

Device Description : Water bottle and cap to be used exclusively with the Aer-O-Scope Colonoscope System

Device Class : 2

Duns Number: 533751681

Premarket Exempt : No

Product Code : FDF

Prescription Use : Yes

Device Count : 1

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