GALIL MEDICAL LTD

Address:YOKNEAM GATE, 1 TAVOR BLDG.,YOKNEAM Northern,IL

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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

Unit, Cryosurgical, Accessories (GEH) (10)

Premarket Exempt

Clear

IceSeed® 1.5 90° Cryoablation Needle - 07290104830235 Catalog Number : FPRPR3202

Device Description : 1.5mm 90 degree Cryoablation Needle

Device Class : 2

Duns Number: 531854560

Premarket Exempt : No

Product Code : GEH

Prescription Use : Yes

Device Count : 1

IceRod® 1.5 90° Cryoablation Needle - 07290104830242 Catalog Number : FPRPR3204

Device Description : 1.5mm 90 degree Cryoablation Needle

Device Class : 2

Duns Number: 531854560

Premarket Exempt : No

Product Code : GEH

Prescription Use : Yes

Device Count : 1

IceSphere® 1.5 90° Cryoablation Needle - 07290104830259 Catalog Number : FPRPR3260

Device Description : 1.5mm 90 degree Cryoablation Needle

Device Class : 2

Duns Number: 531854560

Premarket Exempt : No

Product Code : GEH

Prescription Use : Yes

Device Count : 1

IceSeed® 1.5 MRI Cryoablation Needle - 07290104830266 Catalog Number : FPRPR3192

Device Description : 1.5mm Cryoablation Needle

Device Class : 2

Duns Number: 531854560

Premarket Exempt : No

Product Code : GEH

Prescription Use : Yes

Device Count : 1

IceRod® 1.5 MRI Cryoablation Needle - 07290104830273 Catalog Number : FPRPR3193

Device Description : 1.5mm Cryoablation Needle

Device Class : 2

Duns Number: 531854560

Premarket Exempt : No

Product Code : GEH

Prescription Use : Yes

Device Count : 1

IceSeed® 1.5 MRI 90° Cryoablation Needle - 07290104830280 Catalog Number : FPRPR3194

Device Description : 1.5mm 90 degree Cryoablation Needle

Device Class : 2

Duns Number: 531854560

Premarket Exempt : No

Product Code : GEH

Prescription Use : Yes

Device Count : 1

IceRod® 1.5 MRI 90° Cryoablation Needle - 07290104830297 Catalog Number : FPRPR3195

Device Description : 1.5mm 90 degree Cryoablation Needle

Device Class : 2

Duns Number: 531854560

Premarket Exempt : No

Product Code : GEH

Prescription Use : Yes

Device Count : 1

Multi-Point 1.5 Thermal Sensor™ - 07290104830303 Catalog Number : FPRPR4010

Device Description : 1.5mm Multi-Point Thermal Sensor Cryoablation Needle

Device Class : 2

Duns Number: 531854560

Premarket Exempt : No

Product Code : GEH

Prescription Use : Yes

Device Count : 1

Single-Point 1.5 Thermal Sensor™ MultiPack - 07290104830310 Catalog Number : FPRPR3212

Device Description : 1.5mm Single-Point Thermal Sensor Cryoablation Needle

Device Class : 2

Duns Number: 531854560

Premarket Exempt : No

Product Code : GEH

Prescription Use : Yes

Device Count : 1

Single-Point 1.5 90° Thermal Sensor™ MultiPack - 07290104830327 Catalog Number : FPRPR3206

Device Description : 1.5mm 90 degree Single-Point Thermal Sensor Cryoablation Needle

Device Class : 2

Duns Number: 531854560

Premarket Exempt : No

Product Code : GEH

Prescription Use : Yes

Device Count : 1

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