PALLIARE LIMITED

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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

Insufflator, Laparoscopic (HIF) (2) Adaptor, Bulbs, Miscellaneous, For Endoscope (FFY) (1)

Premarket Exempt

No Yes

Clear

EVA15 - 05391536920005 Catalog Number :

Device Description : LAP300 Laparoscopic Insufflation Tubeset

Device Class : 2

Duns Number: 985710055

Premarket Exempt : No

Product Code : HIF

Prescription Use : Yes

Device Count : 1

EVA15 - 05391536920029 Catalog Number : EVA15

Device Description : Laparoscopic Insufflator and Smoke Evacuation System

Device Class : 2

Duns Number: 985710055

Premarket Exempt : No

Product Code : HIF

Prescription Use : Yes

Device Count : 1

EndoTrap - 05391536920067 Catalog Number :

Device Description : EndoTrap Endoscopist Protection Device

Device Class : 1

Duns Number: 985710055

Premarket Exempt : Yes

Product Code : FFY

Prescription Use : Yes

Device Count : 1

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