T42010

GUDID EPTWT420100

PTW-Freiburg Physikalisch-Technische Werkstätten Dr. Pychlau GmbH

Multi-modality therapeutic radiation phantom, anthropomorphic
Primary Device IDEPTWT420100
NIH Device Record Key5d1a54e7-4330-434a-a294-2bfe7198fa3c
Commercial Distribution StatusIn Commercial Distribution
Version Model NumberLI NACHECK
Catalog NumberT42010
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
HIBCCEPTWT420100 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LHNSystem, Radiation Therapy, Charged-Particle, 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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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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