T41032

GUDID EPTWT410320

PTW-Freiburg Physikalisch-Technische Werkstätten Dr. Pychlau GmbH

Multi-modality therapeutic radiation phantom, test object
Primary Device IDEPTWT410320
NIH Device Record Keye2eca33a-c459-489f-a3eb-a62eb52b6d6b
Commercial Distribution StatusIn Commercial Distribution
Version Model NumberMP1 acrylic water tank, extra lines
Catalog NumberT41032
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
HIBCCEPTWT410320 [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

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