VARIAN MEDICAL SYSTEMS, INC.

Address:6212 Hellyer Ave,San Jose,CA,95138,US

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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

No Yes

Clear

2.4mm Long Shaft PerCryo™ Cryoprobe - 00810563020779 Catalog Number : PCS-24L

Device Description : Right angle 2.4mm cryoprobe, long shaft for use with Cryocare systems (Lead-Free)

Device Class : 2

Duns Number: 009120817

Premarket Exempt : No

Product Code : GEH

Prescription Use : No

Device Count : 1

1.7 mm RenalCryo™ Cryoprobe - 00810563020786 Catalog Number : RS-17

Device Description : Right angle 1.7mm cryoprobe, oblong ice, for use with Cryocare systems

Device Class : 2

Duns Number: 009120817

Premarket Exempt : No

Product Code : GEH

Prescription Use : No

Device Count : 1

1.7 mm RenalCryo™ Cryoprobe - 00810563020793 Catalog Number : RS-17

Device Description : Right angle 1.7mm cryoprobe, oblong ice. for use with Cryocare systems (Lead-Free)

Device Class : 2

Duns Number: 009120817

Premarket Exempt : No

Product Code : GEH

Prescription Use : No

Device Count : 1

1.7 mm Long Shaft RenalCryo™ Cryoprobe - 00810563020809 Catalog Number : RS-17L

Device Description : Right angle 1.7mm cryoprobe, oblong ice, long shaft, for use with Cryocare systems

Device Class : 2

Duns Number: 009120817

Premarket Exempt : No

Product Code : GEH

Prescription Use : No

Device Count : 1

1.7 mm Long Shaft RenalCryo™ Cryoprobe - 00810563020816 Catalog Number : RS-17L

Device Description : Right angle 1.7mm cryoprobe, long shaft, for use with Cryocare systems (Lead-Free)

Device Class : 2

Duns Number: 009120817

Premarket Exempt : No

Product Code : GEH

Prescription Use : No

Device Count : 1

2.4mm RenalCryo™ Cryoprobe - 00810563020823 Catalog Number : RS-24

Device Description : Right angle 2.4m cryoprobe, oblong ice, for use with Cryocare systems

Device Class : 2

Duns Number: 009120817

Premarket Exempt : No

Product Code : GEH

Prescription Use : No

Device Count : 1

2.4mm Long Shaft RenalCryo™ Cryoprobe - 00810563020847 Catalog Number : RS-24L

Device Description : Right angle 2.4mm cryoprobe, oblong ice, long shaft, for use with Cryocare systems

Device Class : 2

Duns Number: 009120817

Premarket Exempt : No

Product Code : GEH

Prescription Use : No

Device Count : 1

3.8 mm RenalCryo™ Cryoprobe - 00810563020861 Catalog Number : R3.8

Device Description : Right angle 3.8mm cryoprobe, oblong ice, for use with Cryocare systems

Device Class : 2

Duns Number: 009120817

Premarket Exempt : No

Product Code : GEH

Prescription Use : No

Device Count : 1

3.8 mm RenalCryo™ Cryoprobe - 00810563020878 Catalog Number : R3.8

Device Description : Right angle 3.8mm cryoprobe, oblong ice, for use with Cryocare systems (Lead-Free)

Device Class : 2

Duns Number: 009120817

Premarket Exempt : No

Product Code : GEH

Prescription Use : No

Device Count : 1

3.8 mm Long Shaft RenalCryo™ Cryoprobe - 00810563020885 Catalog Number : R3.8L

Device Description : Right angle 3.8mm cryoprobe, oblong ice, long shaft, for use with Cryocare systems

Device Class : 2

Duns Number: 009120817

Premarket Exempt : No

Product Code : GEH

Prescription Use : No

Device Count : 1

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