T41017

GUDID EPTWT410170

PTW-Freiburg Physikalisch-Technische Werkstätten Dr. Pychlau GmbH

Multi-modality therapeutic radiation phantom, anthropomorphic
Primary Device IDEPTWT410170
NIH Device Record Keyf25a1568-38e7-4a07-b8c9-7f1ccc6013e2
Commercial Distribution StatusIn Commercial Distribution
Version Model NumberSLA48 2D-air scanner, table-top version
Catalog NumberT41017
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
HIBCCEPTWT410170 [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 Date2017-04-27

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

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EPTWS0700160 - NA2018-07-06
EPTWS1000090 - NA2018-07-06
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