Question 1

What types of medical devices does Varian Medical Systems Deutschland GmbH manufacture?

Accepted Answer

Varian Medical Systems Deutschland GmbH specializes in remote-afterloading brachytherapy systems and associated applicators. These devices are designed for targeted radiation therapy in oncology, including applicators for vaginal, cervical/intrauterine, bronchial, esophageal, and tongue treatments. The company also produces related components like injection needles, source transfer tubes, and accessories such as colpostat segments, intrauterine probes, and fixation rings. These tools are used to precisely localize tumors and deliver radiation during procedures.

Question 2

Where is Varian Medical Systems Deutschland GmbH based, and what is its primary focus?

Accepted Answer

Varian Medical Systems Deutschland GmbH is based in the United States, operating as a subsidiary of a U.S.-based parent company. Its primary focus is on developing and manufacturing remote-afterloading brachytherapy systems and applicators, which are critical for delivering localized radiation therapy in cancer treatment. The company’s portfolio is tailored to support specialized oncology procedures across multiple anatomical sites.

Question 3

In which regulatory registries are Varian Medical Systems Deutschland GmbH’s devices listed?

Accepted Answer

Varian Medical Systems Deutschland GmbH’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry ensures traceability and compliance with U.S. medical device reporting requirements, which is essential for tracking and monitoring devices throughout their lifecycle. Listing in the UDI database is part of the regulatory framework for Class II devices, which require performance-based compliance and post-market surveillance.

Question 4

How are Varian Medical Systems Deutschland GmbH’s devices classified under regulatory frameworks?

Accepted Answer

Varian Medical Systems Deutschland GmbH’s devices are classified as Class II under regulatory frameworks. This classification indicates that while these devices pose moderate risk, they still require compliance with performance-based standards and ongoing post-market surveillance to ensure safety and effectiveness. Class II devices typically undergo rigorous testing and documentation to demonstrate their intended use and performance before authorization.

Question 5

What kinds of accessories and consumables does Varian Medical Systems Deutschland GmbH provide alongside its brachytherapy systems?

Accepted Answer

The company provides a range of accessories and consumables designed to support brachytherapy procedures, including cleaning caps, connecting tubes, mandrin-equipped capsules, and specialized applicator components like colpostat segments, intrauterine probes, and fixation rings. These items are essential for ensuring precise tumor localization, proper radiation delivery, and procedural efficiency. For example, items like the Heyman-capsule with mandrin or surface tubus insets are used to enhance accuracy during treatments.

Device	Model / Reference	Registries	Class	Status
White clamping button, 9.5 mm diameter, pack of 50, non-sterile	GM11003790	FDA UDI	Class II	Active
Handle for lever	GM11009930	FDA UDI	Class II	Active
Triple plane templates, 16 mm hole separation, 5 holes across bottom width	AL07349015	FDA UDI	Class II	Active
Transfer Guide Tube for 500 mm catheters	GM11011900	FDA UDI	Class II	Active
Applicator probe, 6.3 mm diameter x 320 mm, curved 15 degrees, 60 mm	GM11011610	FDA UDI	Class II	Active
Ovoid 20 mm diameter unilateral shielded top Manchester-style	GM11008070	FDA UDI	Class II	Active
SPREADER LOCK PLATE (Right) (CT/MR FSD)	AL10715015	FDA UDI	Class II	Active
Vaginal Cylinder with lever, 30 mm diameter x 50 mm length	GM11009920	FDA UDI	Class II	Active
Esophagus Bougie Set	GM11008880	EUDAMEDFDA UDI	Class II	Active
Nasopharynx Applicator Set	GM11004690	FDA UDI	Class II	Active
Varian Titanium Applicator probe, 3mm dia x 320mm length, curved 15 degree, 50mm	GM11013240	FDA UDI	Class II	Active
Front segment open 20 mm diameter, straight, length 60 mm	GM11004420	FDA UDI	Class II	Active
Colpostat probe (right)	GM11000830	FDA UDI	Class II	Active
Small stabilization rail, length 100 mm	AL07385000	FDA UDI	Class II	Active
Grub screws for clamping unit (pack of 10)	GM11009950	FDA UDI	Class II	Active
Flexible Fixation Device for Gynecological Applicators	GM11001960	FDA UDI	Class II	Active
Titanium Fletcher-style Applicator Set Defined Geometry	GM11006200	FDA UDI	Class II	Active
Varian Universal Titanium Cervix Probe Set, even lengths	GM11013100	FDA UDI	Class II	Active
Double plane templates, 20 mm hole separation, 4 holes across bottom width	AL07349011	FDA UDI	Class II	Unknown
Double plane templates, 12 mm hole separation, 7 holes across bottom width	AL07349007	FDA UDI	Class II	Unknown
Clamping unit for endometrial applicator	GM11009910	FDA UDI	Class II	Active
Template holder	GM11003000	FDA UDI	Class II	Active
Surface cone inset, 15 mm diameter, round	GM11003570	FDA UDI	Class II	Active
Fixation ring for cylinder ø 20 mm	GM11001870	FDA UDI	Class II	Active
Leak stop channel marker set, 13-24	GM11010520	FDA UDI	Class II	Unknown
Ring Applicator Set 90 degree	GM11011210	FDA UDI	Class II	Active
Leak stop channel marker Set, 1-12	GM11010510	FDA UDI	Class II	Unknown
Crook Prostate Template 2.0mm Siemens	GM11012250	FDA UDI	Class II	Active
Varian Titanium Applicator probe, 3mm dia x 320mm length, curved 30 degree, 30mm	GM11013220	FDA UDI	Class II	Active
Double plane templates, 10 mm hole separation, 8 holes across width	AL07349006	FDA UDI	Class II	Active
Channel marker clips, coded 13-24	GM11003770	FDA UDI	Class II	Active
Breast bridge assembly, titanium	AL07375000	FDA UDI	Class II	Active
Complete Accessory Kit for Intraluminal Applicators, GammMedplus	GM11008220	FDA UDI	Class II	Active
Leipzig-style cone 30-45 mm diameter, with holder and guide	GM11010170	FDA UDI	Class II	Active
Colpostat segments for 25 mm spread, pair	GM11000920	FDA UDI	Class II	Active
Colpostat probe (left)	GM11000820	FDA UDI	Class II	Active
Intraluminal Applicator Set	GM11000620	FDA UDI	Class II	Active
Crook Prostate Templates 17 G Siemens	GM11012260	FDA UDI	Class II	Active
Flexible Interstitial Implant Tube Set	GM11004680	FDA UDI	Class II	Active
Clamping segment	GM11005180	FDA UDI	Class II	Active
Intrauterine probe with stop, 30 degrees angle, length 60mm	GM11000870	FDA UDI	Class II	Active
Cervical sleeve 30 mm, with clamp for guide tube	GM11001160	FDA UDI	Class II	Active
Universal fixation button, radiopaque, pack of 100, non-sterile	GM11003800	FDA UDI	Class II	Active
Ring probe 45 degrees, 30 x 36 mm	GM11001240	FDA UDI	Class II	Active
Source guide tube with locking mechanism, third-party applicator, for channel 1	GM11007610	FDA UDI	Class II	Active
Complete Accessory Kit for Interstitial Applicators	GM11008650	FDA UDI	Class II	Active
Mandrin for 320mm length	GM11003100	FDA UDI	Class II	Active
Front segment, 30 mm diameter, centered source position	GM11005120	FDA UDI	Class II	Active
X-ray marker BV, up to 1300 mm catheters, uncoded	GM11009610	FDA UDI	Class II	Active
Segmented Cylinder Applicator Set	GM11004150	FDA UDI	Class II	Unknown

Varian Medical Systems Deutschland GmbH

What Varian Medical Systems Deutschland GmbH makes

Frequently asked questions

Information

Catalogue (490)

Related Companies

Authorised Representatives

Importers

Notified Bodies

Authorities