TN31021

GUDID EPTWTN310210

PTW-Freiburg Physikalisch-Technische Werkstätten Dr. Pychlau GmbH

Ionization chamber radiation measuring probe
Primary Device IDEPTWTN310210
NIH Device Record Keyb7305d96-8f6c-43cf-9967-ab1ed7041bf1
Commercial Distribution StatusIn Commercial Distribution
Version Model NumberSemiflex 3D, 0.07 cm³ ion chamber
Catalog NumberTN31021
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 Numbertrue
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCEPTWTN310210 [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

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