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 (8 m), psi - 00859019006219 Catalog Number : FRPCH4007

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 (8 m), bar - 00859019006226 Catalog Number : FRPCH4008

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

Gas Supply Line (8 m) - 00859019006233 Catalog Number : FPRCH6108

Device Description : Cryoablation System Accessory

Device Class : 2

Duns Number: 809529469

Premarket Exempt : No

Product Code : GEH

Prescription Use : Yes

Device Count : 1

Gas Supply Line (3 m) - 00859019006240 Catalog Number : FPRCH6109

Device Description : Cryoablation System Accessory

Device Class : 2

Duns Number: 809529469

Premarket Exempt : No

Product Code : GEH

Prescription Use : Yes

Device Count : 1

Argon Auxiliary Line (3 m) - 00859019006257 Catalog Number : FPRCH6115

Device Description : Cryoablation System Accessory

Device Class : 2

Duns Number: 809529469

Premarket Exempt : No

Product Code : GEH

Prescription Use : Yes

Device Count : 1

AR Supply Hose, 4.5m, bar - 00859019006264 Catalog Number : FPRCH6118

Device Description : Cryoablation System Accessory

Device Class : 2

Duns Number: 809529469

Premarket Exempt : No

Product Code : GEH

Prescription Use : Yes

Device Count : 1

AR Supply Hose, 4.5m, psi - 00859019006271 Catalog Number : FPRCH6119

Device Description : Cryoablation System Accessory

Device Class : 2

Duns Number: 809529469

Premarket Exempt : No

Product Code : GEH

Prescription Use : Yes

Device Count : 1

HE Supply Hose, 4.5m, bar - 00859019006288 Catalog Number : FPRCH6120

Device Description : Cryoablation System Accessory

Device Class : 2

Duns Number: 809529469

Premarket Exempt : No

Product Code : GEH

Prescription Use : Yes

Device Count : 1

HE Supply Hose, 4.5m, psi - 00859019006295 Catalog Number : FPRCH6121

Device Description : Cryoablation System Accessory

Device Class : 2

Duns Number: 809529469

Premarket Exempt : No

Product Code : GEH

Prescription Use : Yes

Device Count : 1

Supply Hose 4.5m w/o gauge - 00859019006301 Catalog Number : FPRCH6124

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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