ICECURE MEDICAL LTD

Address:7 HaEshel street, POB 3163,Caesarea 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

Guide, Needle, Surgical (GDF) (2) Unit, Cryosurgical, Accessories (GEH) (2)

Premarket Exempt

No Yes

Clear

Introducer D3.5 mm, 122 mm, Trocar. - 07290015487122 Catalog Number : FAC9100000

Device Description : Consists of Mandrel (FAC9100000-1) and Cannula (FAC9100000-2)

Device Class : 1

Duns Number: 514758619

Premarket Exempt : Yes

Product Code : GDF

Prescription Use : Yes

Device Count : 1

Introducer D3.5 mm, 167 mm, Trocar. - 07290015487139 Catalog Number : FAC9200000

Device Description : Consists of Mandrel (FAC9200000-1) and Cannula (FAC9200000-2)

Device Class : 1

Duns Number: 514758619

Premarket Exempt : Yes

Product Code : GDF

Prescription Use : Yes

Device Count : 1

PROSENSE™ SYSTEM 100-127 VAC - 07290015487160 Catalog Number : FAS3000000

Device Class : 2

Duns Number: 514758619

Premarket Exempt : No

Product Code : GEH

Prescription Use : Yes

Device Count : 1

PROSENSE™ SYSTEM 100-127 VAC - 07290015487290 Catalog Number : FAS3000000-2

Device Description : PROSENSE™ SYSTEM 100-127 VAC Straight cryohandle

Device Class : 2

Duns Number: 514758619

Premarket Exempt : No

Product Code : GEH

Prescription Use : Yes

Device Count : 1

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