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

System, applicator, radionuclide, remote-controlled (JAQ) (5) SYSTEM, ABLATION, MICROWAVE AND ACCESSORIES (NEY) (3) UNIT, CRYOSURGICAL, ACCESSORIES (GEH) (2)

Premarket Exempt

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SynchroWave LT Antenna - 00810563021028 Catalog Number : SW-1425

Device Description : Long Tip Microwave Antenna Kit (25 cm, 1 per Tray)

Device Class : 2

Duns Number: 009120817

Premarket Exempt : No

Product Code : NEY

Prescription Use : No

Device Count : 1

SynchroWave ST Antenna - 00810563021035 Catalog Number : SWST-1415

Device Description : Short 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 ST Antenna - 00810563021042 Catalog Number : SWST-1420

Device Description : Short 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

1.7 mm PerCryo™ Cryoprobe - 00810563021059 Catalog Number : PCS-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

2.4mm V-Probe™ Cryoprobe Right Angle with 12 ft Return Hose Length- Lead free - 00810563021684 Catalog Number : CVA2400RA-12

Device Description : Variable ice right angle cryoprobe with 12 ft return hose length for use with Cr Variable ice right angle cryoprobe with 12 ft return hose length for use with Cryocare systems- Lead free solder

Device Class : 2

Duns Number: 009120817

Premarket Exempt : No

Product Code : GEH

Prescription Use : No

Device Count : 1

Universal Quick Connect, reusable, for VariSource Afterloader - 00816389021167 Catalog Number : AL12500000

Device Class : 2

Duns Number: 009120817

Premarket Exempt : No

Product Code : JAQ

Prescription Use : No

Device Count : 1

Universal Quick Connects, reusable, for VariSource Afterloader - 00816389021211 Catalog Number : AL12550000

Device Class : 2

Duns Number: 009120817

Premarket Exempt : No

Product Code : JAQ

Prescription Use : No

Device Count : 1

Colpostat segment, 20mm diameter for three-channel Applicator Sets - 00816389021631 Catalog Number : GM11000680

Device Class : 2

Duns Number: 009120817

Premarket Exempt : No

Product Code : JAQ

Prescription Use : No

Device Count : 1

Center probe mounting for three channel applicators, flexible - 00816389021679 Catalog Number : GM11000770

Device Description : for Fletcher-style Applicator Set (flexible geometry)

Device Class : 2

Duns Number: 009120817

Premarket Exempt : No

Product Code : JAQ

Prescription Use : No

Device Count : 1

Fixation tube for colpostat segments for three-channel Applicator Sets - 00816389021846 Catalog Number : GM11000970

Device Class : 2

Duns Number: 009120817

Premarket Exempt : No

Product Code : JAQ

Prescription Use : No

Device Count : 1

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