T10016

GUDID EPTWT100160

PTW-Freiburg Physikalisch-Technische Werkstätten Dr. Pychlau GmbH

Radiation electrometer
Primary Device IDEPTWT100160
NIH Device Record Key0a3e6ae3-cf06-447a-98bd-918b315f650d
Commercial Distribution StatusIn Commercial Distribution
Version Model NumberTANDEM
Catalog NumberT10016
Company DUNS318749751
Company NamePTW-Freiburg Physikalisch-Technische Werkstätten Dr. Pychlau GmbH
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCEPTWT100160 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

IYEAccelerator, Linear, Medical

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2017-04-26

Devices Manufactured by PTW-Freiburg Physikalisch-Technische Werkstätten Dr. Pychlau GmbH

EPTWS070031 - VERIQA2024-02-16 VERIQA is a software package for display, evaluation and digital processing of medical image data sets and treatment plans in ra
EPTWT100560 - OCTAVIUS2023-12-07
EPTWT100570 - OCTAVIUS2023-12-07
EPTWT100580 - OCTAVIUS2023-12-07
EPTWS0700160 - NA2018-07-06
EPTWS1000090 - NA2018-07-06
EPTWT100040 - MULTIDOS2018-07-06
EPTWT100060 - NA2018-07-06

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