FDA.report

DIADOS

Primary DI
EPTWT110350
Brand
DIADOS
Company
PTW-Freiburg Physikalisch-Technische Werkstätten Dr. Pychlau GmbH
Model
DIADOS E
Catalog number
T11035
Published
2017-04-26
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
LHOInstrument, Quality-Assurance, Radiologic

Product Code Classifications

CodeDeviceSpecialtyClass
LHOInstrument, Quality-Assurance, RadiologicRadiology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
EPTWT110350PrimaryHIBCC0

GMDN Terms

TermDefinition
Multi-modality therapeutic radiation phantom, anthropomorphicA device consisting of preserved human or animal tissue, or a two or three-dimensional (3-D) tissue-equivalent model designed to simulate the functional, physical, or a combination of these characteristics of normal or diseased human organs. It is available in both fixed and variable designs and typically include holders for ionization chambers, dosimeters or radiation measurement instruments. It is a quality assurance (QA) device enabling detailed mapping of therapeutic radiation dose distributions. This dose information is used for quantitative and subjective assessments of the performance of a radiation therapy treatment planning system (RTTPS) and therapeutic radiation delivery systems.

Sterilization Methods

Method

Regulatory Flags

DUNS number
318749751
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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EPTWT100100UNIDOS EUNIDOS ET100102017-04-26
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EPTWT100150NATANDEMT100152017-04-26
EPTWT100160NATANDEMT100162017-04-26
EPTWT100210UNIDOS weblineUNIDOS weblineT100212017-04-26
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EPTWT100370NATANDEM XDRT100372017-04-26
EPTWT100380NATANDEM XDRT100382017-04-26
EPTWT100390NATANDEM XDRT100392017-04-26

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