AccessGUDID - DEVICE: DIAMENTOR (EPTWT110280)

GUDID

Device Identifier (DI) Information

Brand Name: DIAMENTOR
Version or Model: DIAMENTOR K1S for Siemens
Commercial Distribution Status: In Commercial Distribution
Catalog Number: T11028
Company Name: PTW-Freiburg Physikalisch-Technische Werkstätten Dr. Pychlau GmbH

Primary DI Number: EPTWT110280
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?
40624	Multi-modality therapeutic radiation phantom, anthropomorphic	A device consisting of preserved human or animal tissue, or a two or three-dimensional (3-D) tissue-equivalent model designed to simulate the functional, physical, or a combination of these characteristics of normal or diseased human organs. It is available in both fixed and variable designs and typically include holders for ionization chambers, dosimeters or radiation measurement instruments. It is a quality assurance (QA) device enabling detailed mapping of therapeutic radiation dose distributions. This dose information is used for quantitative and subjective assessments of the performance of a radiation therapy treatment planning system (RTTPS) and therapeutic radiation delivery systems.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LHO	Instrument, Quality-Assurance, Radiologic

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes 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: deeadbf3-35de-4e1e-8455-d7acd437245d
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: April 26, 2017