VARIAN MEDICAL SYSTEMS, INC.

Address:3290 Northside Parkway NW Suite 400,Atlanta,GA,30327,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

SYSTEM, ABLATION, MICROWAVE AND ACCESSORIES (NEY) (4) UNIT, CRYOSURGICAL, ACCESSORIES (GEH) (4) Surgical Device, For cutting, coagulation, and/or ablation of tissue, including cardiac tissue (OCL) (2)

Premarket Exempt

No Yes

Clear

3.8 mm Long Shaft RenalCryo™ Cryoprobe - 00810563020892 Catalog Number : R3.8L

Device Description : Right angle 3.8mm 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

TempProbe™ Device - 00810563020908 Catalog Number : CRYO-55-F

Device Description : Temperature probe

Device Class : 2

Duns Number: 009120817

Premarket Exempt : No

Product Code : GEH

Prescription Use : No

Device Count : 1

Prostate Procedure Probe Pack - 00810563020915 Catalog Number : CRYO-204-V

Device Description : Prostate Procedure Kit containing CVA2400 (4ea), CRYO-55-F (6 ea), CRYO-77 ( 1 ea)

Device Class : 2

Duns Number: 009120817

Premarket Exempt : No

Product Code : GEH

Prescription Use : No

Device Count : 1

Prostate Procedure Probe Pack - 00810563020939 Catalog Number : CRYO-207-V

Device Description : Prostate Procedure Kit containing CVA2400 (6ea), CRYO-55-F (6 ea), CRYO-77 ( 1 ea)

Device Class : 2

Duns Number: 009120817

Premarket Exempt : No

Product Code : GEH

Prescription Use : No

Device Count : 1

8mm Cryoprobe - 00810563020953 Catalog Number : CRYO-48-F

Device Description : Straight 8mm cryoprobe for use with Cryocare Systems

Device Class : 2

Duns Number: 009120817

Premarket Exempt : No

Product Code : OCL

Prescription Use : No

Device Count : 1

8mm Cryoprobe - 00810563020960 Catalog Number : CRYO-48-F

Device Description : Straight 8mm cryoprobefor use with Cryocare systems (Lead-Free)

Device Class : 2

Duns Number: 009120817

Premarket Exempt : No

Product Code : OCL

Prescription Use : No

Device Count : 1

MicroThermX Microwave Ablation System - 00810563020984 Catalog Number : MTX-180

Device Description : Mobile Cart

Device Class : 2

Duns Number: 009120817

Premarket Exempt : No

Product Code : NEY

Prescription Use : No

Device Count : 1

MicroThermX Microwave Ablation System - 00810563020991 Catalog Number : MTX180-T2

Device Description : Tabletop Stand

Device Class : 2

Duns Number: 009120817

Premarket Exempt : No

Product Code : NEY

Prescription Use : No

Device Count : 1

SynchroWave LT Antenna - 00810563021004 Catalog Number : SW-1415

Device Description : Long Tip Microwave Antenna Kit (15 cm, 1 per Tray)

Device Class : 2

Duns Number: 009120817

Premarket Exempt : No

Product Code : NEY

Prescription Use : No

Device Count : 1

SynchroWave LT Antenna - 00810563021011 Catalog Number : SW-1420

Device Description : Long Tip Microwave Antenna Kit (20 cm, 1 per Tray)

Device Class : 2

Duns Number: 009120817

Premarket Exempt : No

Product Code : NEY

Prescription Use : No

Device Count : 1

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