AccessGUDID - DEVICE: R2*/T2* Phantom (09355529000088)

GUDID

Device Identifier (DI) Information

Brand Name: R2*/T2* Phantom
Version or Model: v1.0
Commercial Distribution Status: In Commercial Distribution
Catalog Number: -
Company Name: RESONANCE HEALTH ANALYSIS SERVICES PTY LTD

Primary DI Number: 09355529000088
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 740449913 *Terms of Use

Device Description: The R2*/T2* phantom is a medical device accessory intended to be used as an alternative to human test subject to avoid potential complications for an MRI centre in order to evaluate that the scanning protocol have been correctly set up for the analysis of cardiac R2* and T2* values using the CardiacT2* on 1.5T and 3T MRI scanners. The R2*/T2* Phantom consists of an amber bottle having 09 (nine) plastic tubes (30mL) of 0.8% Agarose (C24H38O19) gel doped with varying known concentrations (0.10 mM to 3.2 mM) of manganese chloride (MnCl2).

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?
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
IXG	Phantom, Anthropomorphic, Radiographic

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
Handling Environment Temperature: between 13 and 40 Degrees Celsius
Storage Environment Temperature: between 13 and 40 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: b8352382-be4b-4760-9a08-9dfb48fdc8df
Public Version Date: April 25, 2024
Public Version Number: 1
DI Record Publish Date: April 17, 2024