FDA.reportPublic FDA data

RadQual

Primary DI
00850020470518
Brand
RadQual
Company
RADQUAL, LLC
Model
BM83-30
Device description
Co 57 Rigid Ruler
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
00850020470518PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850020470518008500204705188500204705180850020470518

GMDN Terms#

Term, Definition table
TermDefinition
Radiographic image marker, manualAn object that is manually configured and physically placed within the field of view of a medical or dental diagnostic imaging system [e.g., x-ray, magnetic resonance imaging (MRI), or nuclear medicine] and leaves identifying marks on either films or digital images created using various diagnostic imaging modalities. It can be positioned either on a patient's body, or next to a patient, or be affixed to the film cassette or holder. It is made from materials compatible with the imaging system with which it is intended to be used. Typically used to imprint information on the images related to image acquisition parameters and/or patient identification, and to record anatomical information.

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