RadQual

Basic Information

• Brand Name: RadQual
• Primary DI: 00850020470211
• Version / Model: BM06E-60
• Company Name: RADQUAL, LLC
• Labeler DUNS: 008841076
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-08-03
• Public Version: 1
• Public Version Date: 2020-08-11
• Public Version Status: New
• Public Device Record Key: fa55d110-9add-4568-a345-c6dbc4834219

Device Description

Co 60 "E" Vial

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
IXD	Source, Calibration, Sealed, Nuclear	Radiology	892.1400	1

GMDN Terms

Code	Name	Definition	Implantable	Status
38318	Radionuclide source, quality assurance	A naturally occurring, accelerator produced, or reactor produced radioactive isotope used as a source of radiation in a variety of quality assurance (QA) tests, e.g., markers, daily constancy test, accuracy tests, linearity test, radiation detector operation and calibration of analytical and radiation field instruments. A QA radionuclide source comes in a variety of physical forms, e.g., sealed source, plated/foil source, embedded source or contained radioactive liquids or gels. It may be selected for a particular QA use because of the radiation it emits (alpha particles, beta particles, neutrons, gamma rays, x-rays), its energy spectrum or physical half-life.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00850020470211	GS1