FDA.reportPublic FDA data

RadQual

Primary DI
00850020470365
Brand
RadQual
Company
RADQUAL, LLC
Model
BM06V-10-68
Device description
Ge 68 10cc Multidose Vial
Published
2020-08-03
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
IXDSource, Calibration, Sealed, Nuclear

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IXDSource, Calibration, Sealed, NuclearRadiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850020470365PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850020470365008500204703658500204703650850020470365

GMDN Terms#

Term, Definition table
TermDefinition
Radionuclide source, quality assuranceA 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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
008841076
Device count
1
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850020470020RadQualBM042020-08-07
00850020470037RadQualBM052020-08-07
00850020470044RadQualBM072020-08-07
00850020470051RadQualBM552020-08-07
00850020470068RadQualBM032020-08-03
00850020470075RadQualBM03-22A2020-08-03
00850020470082RadQualBM03-137L2020-08-03
00850020470099RadQualBM03-22L2020-08-03
00850020470105RadQualBM03-22L-PET2020-08-03
00850020470112RadQualBM03-57A2020-08-03
00850020470129RadQualBM03-57L2020-08-03
00850020470136RadQualBM03-57 L&R2020-08-03
00850020470143RadQualBM03-68A2020-08-03
00850020470150RadQualBM03-68L-10C2020-08-03
00850020470167RadQualBM03-68L2020-08-03
00850020470174RadQualBM03-133L2020-08-03
00850020470181RadQualBM06E-332020-08-03
00850020470198RadQualBM06E-372020-08-03
00850020470204RadQualBM06E-572020-08-03
00850020470211RadQualBM06E-602020-08-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810117211387Eckert & Ziegler Isotope Products, Inc.Eckert & Ziegler Isotope Products, Inc.IXD2026-05-14
00810117211370Eckert & Ziegler Isotope Products, Inc.Eckert & Ziegler Isotope Products, Inc.IXD2025-10-30
00810117211332Eckert & Ziegler Isotope Products, Inc.Eckert & Ziegler Isotope Products, Inc.IXD2024-11-05
04068151007923ASM, LS-15 ROD SRCSIEMENS MEDICAL SOLUTIONS USA, INC.IXD2023-11-29
04068151007930ASM, CS-7 QC PHANTOMSIEMENS MEDICAL SOLUTIONS USA, INC.IXD2023-11-29
00850055164017Sanders Medical ProductsSanders Medical Products, Inc.IXD2023-07-27
04056869989082ASM SRC LS-HR+ LINE SRCSSIEMENS MEDICAL SOLUTIONS USA, INC.IXD2023-06-06
04056869989099ASM LINE SRC LS-30 HRRTSIEMENS MEDICAL SOLUTIONS USA, INC.IXD2023-06-06
04056869989105ASM LINE SOURCE MR-PETSIEMENS MEDICAL SOLUTIONS USA, INC.IXD2023-06-06
04056869989112ASSEMBLY MR PET QC PHANTOMSIEMENS MEDICAL SOLUTIONS USA, INC.IXD2023-06-06
04056869989129SM SRC CS-20-1 UNIFORM PHANTOMSIEMENS MEDICAL SOLUTIONS USA, INC.IXD2023-06-06
04056869989136SRC PHANTOM CS 20-2 GE68 2 MCI PLYUSIEMENS MEDICAL SOLUTIONS USA, INC.IXD2023-06-06
04056869989143ASM SRC CS-20-3 UNIFORM PHANTOMSIEMENS MEDICAL SOLUTIONS USA, INC.IXD2023-06-06
04056869989150SRC CS-HT-27-2 UNIFORM PHANTOMSIEMENS MEDICAL SOLUTIONS USA, INC.IXD2023-06-06
04056869989068ASM ACCEL LINE SRCSSIEMENS MEDICAL SOLUTIONS USA, INC.IXD2023-06-05
04056869989075ASM SRC LS-EXACT LINE SRCSSIEMENS MEDICAL SOLUTIONS USA, INC.IXD2023-06-05
04056869989051ASM SRC LS-LA DET SET UP RODSIEMENS MEDICAL SOLUTIONS USA, INC.IXD2023-06-01
00810117211318Eckert & Ziegler Isotope Products, Inc.Eckert & Ziegler Isotope Products, Inc.IXD2023-01-31
00810117210014Eckert & Ziegler Isotope Products, Inc.Eckert & Ziegler Isotope Products, Inc.IXD2022-12-07
00810117210021Eckert & Ziegler Isotope Products, Inc.Eckert & Ziegler Isotope Products, Inc.IXD2022-12-07
00810117210038Eckert & Ziegler Isotope Products, Inc.Eckert & Ziegler Isotope Products, Inc.IXD2022-12-07
00810117210045Eckert & Ziegler Isotope Products, Inc.Eckert & Ziegler Isotope Products, Inc.IXD2022-12-07
00810117210052Eckert & Ziegler Isotope Products, Inc.Eckert & Ziegler Isotope Products, Inc.IXD2022-12-07
00810117210069Eckert & Ziegler Isotope Products, Inc.Eckert & Ziegler Isotope Products, Inc.IXD2022-12-07
00810117210076Eckert & Ziegler Isotope Products, Inc.Eckert & Ziegler Isotope Products, Inc.IXD2022-12-07
00810117210083Eckert & Ziegler Isotope Products, Inc.Eckert & Ziegler Isotope Products, Inc.IXD2022-12-07
00810117210090Eckert & Ziegler Isotope Products, Inc.Eckert & Ziegler Isotope Products, Inc.IXD2022-12-07
00810117210106Eckert & Ziegler Isotope Products, Inc.Eckert & Ziegler Isotope Products, Inc.IXD2022-12-07
00810117210113Eckert & Ziegler Isotope Products, Inc.Eckert & Ziegler Isotope Products, Inc.IXD2022-12-07
00810117210120Eckert & Ziegler Isotope Products, Inc.Eckert & Ziegler Isotope Products, Inc.IXD2022-12-07