AccessGUDID - DEVICE: Geometric QA Phantom (00884838068506)

GUDID

Device Identifier (DI) Information

Brand Name: Geometric QA Phantom
Version or Model: 459800438932
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Philips Oy

Primary DI Number: 00884838068506
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 539852079 *Terms of Use

Device Description: The Geometric Quality Assurance Phantom is intended to provide the operator with spatial reference information that can aid the operator to assess whether or not the amount of geometric distortions of the MR scanner is acceptable for the intended application.

Device Characteristics

What MRI safety information does the labeling contain?	MR Safe
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?
40636	MRI phantom, test object	A device that consists of a uniform density, or a two or three-dimensional (3-D) pattern of objects, materials or openings of varying dimensions and material densities. It is available in both fixed and variable configurations and is a quality assurance (QA) device used in both subjective and quantitative evaluations of various calibration and performance characteristics of magnetic resonance imaging (MRI) systems or magnetic resonance spectroscopy systems and associated image acquisition, display, and analysis computer programs.	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: 2a6fc827-a460-47f2-ad39-a6a8f3998484
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: September 23, 2016