AccessGUDID - DEVICE: QUASAR (G34310010231000)

GUDID

Device Identifier (DI) Information

Brand Name: QUASAR
Version or Model: 100-1023-100
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Modus Medical Devices Inc

Primary DI Number: G34310010231000
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 201924631 *Terms of Use

Device Description: QUASAR MRgRT Insight (MRDQA) Phantom - Support Base Package. Includes Support base and upright sections with 1 laser alignment target, User’s Guide, Heavy Duty Case, and software for 1 MR scanner with unlimited scans.

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):	No
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?
40631	Multi-modality therapeutic radiation phantom, test object	A device consisting of a variety of multi-modality radiation therapy phantom designs. It can consist of an object of uniform material density or a two or three-dimensional (3-D) model containing patterns of objects, materials, or openings. It is available in both fixed and variable configurations including holders for ionization chambers, dosimeters or other radiation measurement instruments. It is a quality assurance (QA) device used in the calibration of photon and electron beam emitting radiation therapy systems and the measurement of performance attributes, e.g., beam flatness, symmetry, dose depth or geometric accuracy.	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: f9eda08d-de4d-4554-8492-60f6438cb0a7
Public Version Date: June 04, 2025
Public Version Number: 2
DI Record Publish Date: April 15, 2024