VARIAN MEDICAL SYSTEMS, INC.

Address:Corredor Tijuana-Rosarito, No 21702 col. El Realito,Tijuana Baja California,MX

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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

System, applicator, radionuclide, remote-controlled (JAQ) (10)

Premarket Exempt

No Yes

Clear

Mandrin for 200mm length Needle for Plastic Interstitial Needle - 00816389022522 Catalog Number : GM11003270

Device Class : 2

Duns Number: 009120817

Premarket Exempt : No

Product Code : JAQ

Prescription Use : No

Device Count : 1

Stainless steel needle, 113mm, 1.65mm diameter, trocar point - 00816389022560 Catalog Number : GM11003350

Device Description : For Prostate and Perineal Implant Template Set, Breast Implant Template Set, Int For Prostate and Perineal Implant Template Set, Breast Implant Template Set, Interstitial Applicator Set

Device Class : 2

Duns Number: 009120817

Premarket Exempt : No

Product Code : JAQ

Prescription Use : No

Device Count : 1

Surface cone inset, 20 mm, diameter for Surface Applicator Set (HDR use only) - 00816389022836 Catalog Number : GM11003680

Device Class : 2

Duns Number: 009120817

Premarket Exempt : No

Product Code : JAQ

Prescription Use : No

Device Count : 1

Fixation screw with nut for Cervix Applicator Set - 00816389023567 Catalog Number : GM11005230

Device Class : 2

Duns Number: 009120817

Premarket Exempt : No

Product Code : JAQ

Prescription Use : No

Device Count : 1

Titanium Colpostat Probe (left) - 00816389023680 Catalog Number : GM11006110

Device Description : For Titanium Fletcher-style Applicator Set (CT & MR compatible, flexible geometry)

Device Class : 2

Duns Number: 009120817

Premarket Exempt : No

Product Code : JAQ

Prescription Use : No

Device Count : 1

Titanium Colpostat Probe (right), Titanium - 00816389023697 Catalog Number : GM11006120

Device Description : For Titanium Fletcher-style Applicator Set (CT & MR compatible, flexible geometry)

Device Class : 2

Duns Number: 009120817

Premarket Exempt : No

Product Code : JAQ

Prescription Use : No

Device Count : 1

Titanium intrauterine probe, 15 degrees angle, Titanium - 00816389023819 Catalog Number : GM11006680

Device Description : For Titanium Fletcher-style Applicator Set (CT & MR compatible, flexible geometry)

Device Class : 2

Duns Number: 009120817

Premarket Exempt : No

Product Code : JAQ

Prescription Use : No

Device Count : 1

Titanium intrauterine probe, 30 degrees angle, Titanium - 00816389023826 Catalog Number : GM11006690

Device Description : For Titanium Fletcher-style Applicator Set (CT & MR compatible, flexible geometry)

Device Class : 2

Duns Number: 009120817

Premarket Exempt : No

Product Code : JAQ

Prescription Use : No

Device Count : 1

Titanium intrauterine probe, 45 degrees angle, Titanium - 00816389023833 Catalog Number : GM11006700

Device Description : For Titanium Fletcher-style Applicator Set (CT & MR compatible, flexible geometry)

Device Class : 2

Duns Number: 009120817

Premarket Exempt : No

Product Code : JAQ

Prescription Use : No

Device Count : 1

Titanium forceps clamping mechanism - 00816389023895 Catalog Number : GM11006800

Device Description : For Titanium Fletcher-style Applicator Set Defined Geometry

Device Class : 2

Duns Number: 009120817

Premarket Exempt : No

Product Code : JAQ

Prescription Use : No

Device Count : 1

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