GALIL MEDICAL LTD

Address:YOKNEAM GATE, 1 TAVOR BLDG.,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

Unit, Cryosurgical, Accessories (GEH) (5) System, Ablation, Microwave And Accessories (NEY) (2)

Premarket Exempt

Clear

Three IceFORCE ® 2.1 CX Prostate Cryoablation Kit Visual-ICE® System - 07290104831058 Catalog Number : FPRPR3607

Device Description : Prostate Kit including Cryoablation Needles, Thermal Sensor, Urethral Warming Se Prostate Kit including Cryoablation Needles, Thermal Sensor, Urethral Warming Set, Prostate Template

Device Class : 2

Duns Number: 531854560

Premarket Exempt : No

Product Code : GEH

Prescription Use : Yes

Device Count : 1

Three IcePearl® 2.1 CX Prostate Cryoablation KitVisual-ICE® System - 07290104831065 Catalog Number : FPRPR3608

Device Class : 2

Duns Number: 531854560

Premarket Exempt : No

Product Code : GEH

Prescription Use : Yes

Device Count : 1

IcePearl™ 2.1 CX L 90° Cryoablation Needle - 07290104831072 Catalog Number : FPRPR3617

Device Description : 2.1 mm 90 degree Cryoablation Needle

Device Class : 2

Duns Number: 531854560

Premarket Exempt : No

Product Code : GEH

Prescription Use : Yes

Device Count : 1

IceFORCE™ 2.1 CX L 90° Cryoablation Needle - 07290104831089 Catalog Number : FPRPR3618

Device Class : 2

Duns Number: 531854560

Premarket Exempt : No

Product Code : GEH

Prescription Use : Yes

Device Count : 1

IceSphere™ 1.5 CX Cryoablation Needle - 07290104831133 Catalog Number : FPRPR3573

Device Description : 1.5 mm Cryoablation Needle

Device Class : 2

Duns Number: 531854560

Premarket Exempt : No

Product Code : GEH

Prescription Use : Yes

Device Count : 1

MultiPoint 1.5 Thermal Sensor - 07290104831164 Catalog Number : FPRPR4020

Device Description : 1.5mm Multi-Point Thermal Sensor (MTS)

Device Class : 2

Duns Number: 531854560

Premarket Exempt : No

Product Code : NEY

Prescription Use : Yes

Device Count : 1

MultiPoint 1.5 Thermal Sensor - 07290104831195 Catalog Number : FPRPR4020-02

Device Description : 1.5mm Multi-Point Thermal Sensor (MTS)

Device Class : 2

Duns Number: 531854560

Premarket Exempt : No

Product Code : NEY

Prescription Use : Yes

Device Count : 1

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