GALIL MEDICAL INC.

Address:4364 Round Lake Road,Arden Hills,MN,55112,US

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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) (10)

Premarket Exempt

Clear

EZ CONNECT2™ Dual Cylinder Adapter, psi - 00859019006004 Catalog Number : FPRCH4000

Device Description : Visual-ICE Cryoablation System Accessory

Device Class : 2

Duns Number: 809529469

Premarket Exempt : No

Product Code : GEH

Prescription Use : Yes

Device Count : 1

EZ CONNECT2™ Dual Cylinder Adapter, bar - 00859019006011 Catalog Number : FPRCH4001

Device Description : Visual-ICE Cryoablation System Accessory

Device Class : 2

Duns Number: 809529469

Premarket Exempt : No

Product Code : GEH

Prescription Use : Yes

Device Count : 1

Argon Supply Line (8 m), bar - 00859019006028 Catalog Number : FPRCH6100

Device Description : Cryoablation System Accessory

Device Class : 2

Duns Number: 809529469

Premarket Exempt : No

Product Code : GEH

Prescription Use : Yes

Device Count : 1

Helium Supply Line (8 m), bar - 00859019006035 Catalog Number : FPRCH6101

Device Description : Cryoablation System Accessory

Device Class : 2

Duns Number: 809529469

Premarket Exempt : No

Product Code : GEH

Prescription Use : Yes

Device Count : 1

Argon Supply Line (3 m), bar - 00859019006042 Catalog Number : FPRCH6103

Device Description : Cryoablation System Accessory

Device Class : 2

Duns Number: 809529469

Premarket Exempt : No

Product Code : GEH

Prescription Use : Yes

Device Count : 1

Helium Supply Line (3 m), bar - 00859019006059 Catalog Number : FPRCH6105

Device Description : Cryoablation System Accessory

Device Class : 2

Duns Number: 809529469

Premarket Exempt : No

Product Code : GEH

Prescription Use : Yes

Device Count : 1

Argon Supply Line (8 m), psi - 00859019006066 Catalog Number : FPRCH6106

Device Description : Cryoablation System Accessory

Device Class : 2

Duns Number: 809529469

Premarket Exempt : No

Product Code : GEH

Prescription Use : Yes

Device Count : 1

Helium Supply Line (8 m), psi - 00859019006073 Catalog Number : FPRCH6107

Device Description : Cryoablation System Accessory

Device Class : 2

Duns Number: 809529469

Premarket Exempt : No

Product Code : GEH

Prescription Use : Yes

Device Count : 1

Argon Supply Line (5 m), psi - 00859019006080 Catalog Number : FPRCH6127

Device Description : Cryoablation System Accessory

Device Class : 2

Duns Number: 809529469

Premarket Exempt : No

Product Code : GEH

Prescription Use : Yes

Device Count : 1

Argon Supply Line (5 m), bar - 00859019006097 Catalog Number : FPRCH6128

Device Description : Cryoablation System Accessory

Device Class : 2

Duns Number: 809529469

Premarket Exempt : No

Product Code : GEH

Prescription Use : Yes

Device Count : 1

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