T41015

GUDID EPTWT410150

PTW-Freiburg Physikalisch-Technische Werkstätten Dr. Pychlau GmbH

Multi-modality therapeutic radiation phantom, anthropomorphic
Primary Device IDEPTWT410150
NIH Device Record Key675977a4-b183-40c8-9a82-ecf2f74d57b7
Commercial Distribution StatusIn Commercial Distribution
Version Model NumberSLA48 2D-air scanner with head mount
Catalog NumberT41015
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
HIBCCEPTWT410150 [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
EPTWT100040 - MULTIDOS2018-07-06
EPTWT100060 - NA2018-07-06

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