FDA.reportPublic FDA data

Eckert & Ziegler Isotope Products, Inc.

Primary DI
00810117211370
Brand
Eckert & Ziegler Isotope Products, Inc.
Company
Eckert & Ziegler Isotope Products, Inc.
Model
A3432-3
Device description
Quality Assurance Line Source
Published
2025-10-30
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
00810117211370PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810117211370008101172113708101172113700810117211370

GMDN Terms#

Term, Definition table
TermDefinition
Nuclear medicine phantom, line sourceA device which is either a linear radioactive sealed source or refillable linear radiolucent tube to which radioactivity can be added. It is a quality assurance (QA) device used in both subjective and quantitative evaluations of various calibration and performance characteristics of photon detector systems used in nuclear medicine imaging applications and associated image acquisition, display and analysis computer programs.

Regulatory Flags#

DUNS number
041668633
Device count
1
DM exempt
true
Premarket exempt
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810117211387Eckert & Ziegler Isotope Products, Inc.A1910-42026-05-14
00810117211363Eckert & Ziegler Isotope Products, Inc.A19522025-10-30
00810117211332Eckert & Ziegler Isotope Products, Inc.A34482024-11-05
00810117211318Eckert & Ziegler Isotope Products, Inc.A19402023-01-31
00810117210014Eckert & Ziegler Isotope Products, Inc.A19462022-12-07
00810117210021Eckert & Ziegler Isotope Products, Inc.A32092022-12-07
00810117210038Eckert & Ziegler Isotope Products, Inc.A3209-22022-12-07
00810117210045Eckert & Ziegler Isotope Products, Inc.A3224-0502022-12-07
00810117210052Eckert & Ziegler Isotope Products, Inc.A3224-0102022-12-07
00810117210069Eckert & Ziegler Isotope Products, Inc.A32412022-12-07
00810117210076Eckert & Ziegler Isotope Products, Inc.A32392022-12-07
00810117210083Eckert & Ziegler Isotope Products, Inc.A3412-72022-12-07
00810117210090Eckert & Ziegler Isotope Products, Inc.A3239-12022-12-07
00810117210106Eckert & Ziegler Isotope Products, Inc.A3402-C120002022-12-07
00810117210113Eckert & Ziegler Isotope Products, Inc.A3402-C162852022-12-07
00810117210120Eckert & Ziegler Isotope Products, Inc.A34322022-12-07
00810117210137Eckert & Ziegler Isotope Products, Inc.A3432-22022-12-07
00810117210144Eckert & Ziegler Isotope Products, Inc.A3412-52022-12-07
00810117210151Eckert & Ziegler Isotope Products, Inc.A3441-12022-12-07
00810117210168Eckert & Ziegler Isotope Products, Inc.A34422022-12-07

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
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
00810117210137Eckert & Ziegler Isotope Products, Inc.Eckert & Ziegler Isotope Products, Inc.IXD2022-12-07