BELLUSCURA PLC

Address:5504 Democracy Drive,Plano,TX,75024,US

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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

Generator, Oxygen, Portable (CAW) (1) Laparoscope, General & Plastic Surgery (GCJ) (1)

Premarket Exempt

Clear

X-PLO2R - 00850029991007 Catalog Number :

Device Description : Portable oxygen concentrator

Device Class : 2

Duns Number: 221297691

Premarket Exempt : No

Product Code : CAW

Prescription Use : Yes

Device Count : 1

Passport SmartTip Trocar - 00869257000306 Catalog Number : 0260-285-100

Device Description : THe Passport SmartTip Trocar is an access device that create and maintain a pass THe Passport SmartTip Trocar is an access device that create and maintain a passageway for laparoscopic instruments during a variety of laparoscopic procedures, such as general, gynecologic, thoracic, and urological procedures in adult and adolescent (12 to 21 years of age) populations. The Passport SmartTip Trocar is a single use disposable device, not to be resterilized.

Device Class : 2

Duns Number: 221297691

Premarket Exempt : No

Product Code : GCJ

Prescription Use : Yes

Device Count : 1

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