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
Front segment open 25 mm diameter, straight, length 60 mm	GM11004220	FDA UDI	Class II	Active
Open CT vaginal-cylinder, 23 mm diameter, length 140 mm	GM11005270	FDA UDI	Class II	Active
Bite protector, 8 mm diameter (with strap)	GM11007450	FDA UDI	Class II	Active
Applicator probe, 6.3 mm diameter x 320 mm, straight, 70 mm	GM11011630	FDA UDI	Class II	Active
Cleaning caps green (pack of 20)	GM11003030	FDA UDI	Class II	Active
Fixation strap 1700 mm/500 mm	GM11001950	FDA UDI	Class II	Active
Inner tube for centering catheter, sterile, single use	GM11008160	FDA UDI	Class II	Active
Varian Titanium Applicator probe, 3mm dia x 320mm length, curved 30 degree, 40mm	GM11013120	FDA UDI	Class II	Active
Surface tubus inset, 30-45mm diameter, round	GM11003670	FDA UDI	Class II	Active
Template pair, with 5 holes in equilateral triangles of 18mm	GM11002840	FDA UDI	Class II	Unknown
PDR quick connector socket, 11-15, patient side	GM11007150	FDA UDI	Class II	Active
Varian Titanium Applicator probe, 3mm dia x 320mm length, curved 45 degree, 30mm	GM11013230	FDA UDI	Class II	Active
Applicator probe, 6.3 mm diameter x 320 mm, straight, 50 mm	GM11011570	FDA UDI	Class II	Active
Thumbscrew for Kelowna GYN templates	GM11012320	FDA UDI	Class II	Active
Varian Titanium Applicator probe, 3mm dia x 320mm length, curved 30 degree, 60mm	GM11013150	FDA UDI	Class II	Active
Open CT vaginal-cylinder, 26 mm diameter, length 140 mm	GM11005290	FDA UDI	Class II	Active
Crook Prostate Template 17 G B&K	GM11012240	FDA UDI	Class II	Active
Applicator Wrench (ct/Mr Fsd)	AL10715022	FDA UDI	Class II	Active
Plexiglas filler piece 90 degrees	GM11003890	FDA UDI	Class II	Active
Ring probe 45 degrees, 26 x 32 mm	GM11001230	FDA UDI	Class II	Active
Needle securing Allen tool	AL07346000	FDA UDI	Class II	Active
Titanium needle 250 mm, 16 gauge (1.65 mm), sharp trocar point	GM11010230	FDA UDI	Class II	Active
Triple plane templates, 14 mm hole separation, 7 holes across bottom width	AL07349014	FDA UDI	Class II	Unknown
Template pair, with 7 holes in single line, spacing 18mm	GM11002790	FDA UDI	Class II	Unknown
Length cutting gauge, 113mm for implant tubes and breast applicators up to 6 Fr.	GM11010000	FDA UDI	Class II	Active
X-ray marker wire, 160 cm x 0.6, channel 4	AL13134000	FDA UDI	Class II	Active
Small component box to store small componenets during reprocessing	GM11012300	FDA UDI	Class II	Active
Ovoid Interface Band (ct/Mr Fsd)	AL10715023	FDA UDI	Class II	Active
Fixation strap 1050 mm/350 mm	GM11001940	FDA UDI	Class II	Active
Titanium needle 320 mm, 16 gauge (1.65 mm), sharp trocar point	GM11010240	FDA UDI	Class II	Active
Shielded cylinder, 26 mm diameter	GM11003400	FDA UDI	Class II	Active
Marking screw, 90 degrees shielded	GM11003450	FDA UDI	Class II	Active
Esophagus bougie diameter 8 mm, with bite protector and fixation	GM11007410	FDA UDI	Class II	Active
Varian Titanium Applicator probe, 3mm dia x 320mm length, curved 45 degree, 50mm	GM11013260	FDA UDI	Class II	Active
Surface cone inset, 10 mm diameter, round	GM11003560	FDA UDI	Class II	Active
Crook Prostate Template 2.0mm B&K	GM11012230	FDA UDI	Class II	Active
Closed CT vaginal-cylinder, 20 mm diameter, with plastic clamping screw	GM11004760	FDA UDI	Class II	Active
SET SCREW 6-32 x 3/16 LG (CT/MR FSD)	AL10715020	FDA UDI	Class II	Active
Cylinder segment, 30 mm diameter, 30 mm length	GM11005130	FDA UDI	Class II	Active
cleaning set for esophagus bougies	GM11004720	FDA UDI	Class II	Active
Length Gauge, GammaMedplus	GM11000330	FDA UDI	Class II	Active
Length cutting gauge, 200mm for implant tubes and breast applicators up to 6 Fr.	GM11010010	FDA UDI	Class II	Active
Fletcher-style Applicator Set Defined Geometry	GM11000810	FDA UDI	Class II	Active
Colpostats for 30mm spread, pair	GM11000930	FDA UDI	Class II	Active
Intrauterine probe angle 15 degrees	GM11004450	FDA UDI	Class II	Active
Intrauterine probe with stop, 30 degrees angle, length 80mm	GM11000890	FDA UDI	Class II	Active
Blank templates, size B-24 mm x 70 mm	AL07349019	FDA UDI	Class II	Unknown
Tube catheter 3.2 mm diameter, GammaMedplus	GM11000400	FDA UDI	Class II	Active
Template pair, with 9 holes in equilateral triangles of 18mm	GM11002690	FDA UDI	Class II	Unknown
Tandem Rotate & Slide Block (ct/Mr Fsd)	AL10715008	FDA UDI	Class II	Active

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