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
Marking screw, 180 degrees, shielded	GM11003470	FDA UDI	Class II	Active
Colpostat segments for 20 mm spread, pair	GM11000910	FDA UDI	Class II	Active
4 cm intrauterine probe angled 20 degrees, for 3-channel applicator	GM11007820	FDA UDI	Class II	Active
Fixation ring for cylinder ø 40 mm	GM11011480	FDA UDI	Class II	Active
PDR quick connector 01-05, unit side, GammaMedplus	GM11007090	FDA UDI	Class II	Active
Front end segment 35 mm diameter, 57.5 mm length	GM11011060	FDA UDI	Class II	Active
Cleaning caps, blue (pack of 20)	GM11009420	FDA UDI	Class II	Active
Intrauterine tandems, right and left, 320 mm length, angle 20 degrees x 90 mm	GM11009890	FDA UDI	Class II	Active
Surface tubus inset, 10-25mm diameter, round	GM11003660	FDA UDI	Class II	Active
Connecting tube 320mm interstitial tube for PDR quick connector (1 per channel)	GM11007220	FDA UDI	Class II	Active
Heyman-capsule, 4mm diameter x 17.5mm length, with mandrin for 320 mm needles	GM11005280	FDA UDI	Class II	Active
Titanium acetal, cervical stop	AL07338000	FDA UDI	Class II	Active
Front segment, 25 mm diameter, centered source position	GM11005190	FDA UDI	Class II	Active
Front segment open 30 mm diameter, straight, length 60 mm	GM11004350	FDA UDI	Class II	Active
Breast Bridge	AL07345000	FDA UDI	Class II	Active
Ear, nose & throat mould without balloons, with two guide tubes, sterile	GM11003320	FDA UDI	Class II	Active
Cylinder segment, 35 mm diameter, 30 mm length	GM11005160	FDA UDI	Class II	Active
Complete Kit for Heyman Packing Applicator & Catheter Flap Sets, GammaMed	GM11008310	FDA UDI	Class II	Active
Varian Titanium Applicator probe, 3mm dia x 320mm length, curved 45 degree, 40mm	GM11013130	FDA UDI	Class II	Active
Bronchial catheter, 1.84 mm diameter, sterile	GM11002260	FDA UDI	Class II	Unknown
UNSHIELDED OVOID 16mm (CT/MR FSD)	AL10734000	FDA UDI	Class II	Active
Front segment open 35 mm diameter, 15 degrees curved, length 60 mm	GM11004290	FDA UDI	Class II	Active
Varian Titanium Applicator probe, 3mm dia x 320mm length, curved 30 degree, 80mm	GM11013180	FDA UDI	Class II	Active
Intrauterine tandems, right and left, 320 mm length, angle 20 degrees x 50 mm	GM11009850	FDA UDI	Class II	Active
Heyman-capsule, 6mm diameter x 17.5mm length, with mandrin for 320 mm needles	GM11005110	FDA UDI	Class II	Active
UNSHIELDED OVOID PAIR 20mm (CT/MR FSD)	AL10735000	FDA UDI	Class II	Active
Blue clamping button, 9.5 mm diameter, pack of 50, non-sterile	GM11003760	FDA UDI	Class II	Active
Double plane templates, 14 mm hole separation, 6 holes across bottom width	AL07349008	FDA UDI	Class II	Unknown
Cervical sleeve 50 mm, with clamp for guide tube	GM11001170	FDA UDI	Class II	Active
PDR quick connector, 16-20, unit side, GammaMedplus	GM11007120	FDA UDI	Class II	Active
5 cm intrauterine probe angled 20 degrees, for 3-channel applicator	GM11007830	FDA UDI	Class II	Active
Plastic needle ø 2.0 mm diameter, 320 mm length with mandrin for 320 mm needles	GM11007580	FDA UDI	Class II	Active
Length cutting gauge, 250mm for implant tubes and breast applicators up to 6 Fr.	GM11010030	FDA UDI	Class II	Active
Front segment open 30 mm diameter, 15 degrees curved, length 60 mm	GM11004260	FDA UDI	Class II	Active
Needle securing collets for fixation of needles to templates, set of 10	AL07348000	FDA UDI	Class II	Active
VariSource VS2000 HDR Ir 192 Brachytherapy Sealed Source	AL09400000	FDA UDI	Class II	Active
Front segment, 35 mm diameter, centered source position	GM11005150	FDA UDI	Class II	Active
Applicator probe 6/3 mm diameter, curved 15 degrees, length 320 mm	GM11002230	FDA UDI	Class II	Unknown
Colpostat probe (right) Manchester-style	GM11006880	FDA UDI	Class II	Active
Blank templates, size A-16 mm x 70 mm	AL07349018	FDA UDI	Class II	Unknown
Single plane templates, 20 mm hole separation, 4 holes across width	AL07349005	FDA UDI	Class II	Unknown
Cervix Applicator Set	GM11004040	FDA UDI	Class II	Unknown
3D Interstitial Ring Applicator Set 90 degree	GM11010290	FDA UDI	Class II	Active
Colpostat probe (left) Manchester-style	GM11006870	FDA UDI	Class II	Active
Breast Bridge and Template System	AL13011000	FDA UDI	Class II	Unknown
Front segment open 20 mm diameter, 15 degrees curved, length 60 mm	GM11004200	FDA UDI	Class II	Active
Single plane templates, 16 mm hole separation, 5 holes across width	AL07349003	FDA UDI	Class II	Active
Medium stabilization rail, length 150 mm	AL07386000	FDA UDI	Class II	Active
Heyman-capsule, 8mm diameter x 17.5mm length, with mandrin for 320 mm needles	GM11005040	FDA UDI	Class II	Active
Stump Applicator Set with CT Cylinders	GM11004160	FDA UDI	Class II	Unknown

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