AccessGUDID - DEVICE: NA (EPTWTN600200)

GUDID

Device Identifier (DI) Information

Brand Name: NA
Version or Model: Dosimetry Diode PR
Commercial Distribution Status: In Commercial Distribution
Catalog Number: TN60020
Company Name: PTW-Freiburg Physikalisch-Technische Werkstätten Dr. Pychlau GmbH

Primary DI Number: EPTWTN600200
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 318749751 *Terms of Use

Device Description: No description.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
38326	Ionization chamber radiation measuring probe	An electrically isolated or electronically connected gas-filled radiation detection chamber operated in the "ionization chamber" voltage region. It is used with portable survey meters, stationary radiation monitors or analytical counting instruments. The incident radiation sets up a characteristic "saturated current" within the chamber. A number of probes with different size chambers and chamber wall thicknesses are needed to cover the possible range of radiation energies and doses. It is very stable over time and may be used for accurate dosimetry measurements, e.g., source calibrations and inter-comparisons. For accurate measurements, temperature and pressure corrections are needed.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
IYE	Accelerator, Linear, Medical

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K010916	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 3f292d0f-3b0c-4fb0-8957-29d47c00f21b
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: April 27, 2017