DEVICE: ProBeam Proton Therapy System (00858991006019)

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Device Identifier (DI) Information

ProBeam Proton Therapy System
3.0

Varian Medical Systems Deutschland GmbH
00858991006019
GS1
1
Fixed Beam
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
No
No
No
No
No

GMDN

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GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Proton therapy system An assembly of devices/systems designed to produce and deliver a transverse- and longitudinal-dose proton beam to treat localized tumours and other conditions susceptible to treatment by radiation. A proton therapy system (PTS) consists of two main components: 1) the beam production equipment, which includes a cyclotron and beam transport and switching system (BTS); and 2) the beam delivery system (BDS), which directs the proton beam to the patient target site. It also typically includes a therapy safety system (TSS) with manual/automatic shut down controls, a computer-based beam parameter control system, and the necessary operating and application software.
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FDA Product Code

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Product Code Product Code Name
LHN System, radiation therapy, charged-particle, medical
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Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

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Storage and Handling
No storage/handling found
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Status

In Commercial Distribution
September 21, 2016

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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

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No
No
None
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Production Identifier(s) in UDI

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No
Yes
No
Yes
No CLOSE

Customer Contact

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No Customer Contact currently defined
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