FDA.reportPublic FDA data

Eckert & Ziegler Isotope Products, Inc.

Primary DI
00810117210342
Brand
Eckert & Ziegler Isotope Products, Inc.
Company
Eckert & Ziegler Isotope Products, Inc.
Model
1943-2
Device description
Quality Assurance Phantom Source
Published
2022-12-07
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
JARPhantom, Test-Pattern, Radionuclide

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JARPhantom, Test-Pattern, RadionuclideRadiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810117210342PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810117210342008101172103428101172103420810117210342

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
041668633
Device count
1
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
00810117211370Eckert & Ziegler Isotope Products, Inc.A3432-32025-10-30
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05060608882038Capintec NEMA IEC NM Body PhantomSUN NUCLEAR CORP.JAR2025-11-07
00810117210311Eckert & Ziegler Isotope Products, Inc.Eckert & Ziegler Isotope Products, Inc.JAR2022-12-07
00810117210328Eckert & Ziegler Isotope Products, Inc.Eckert & Ziegler Isotope Products, Inc.JAR2022-12-07
00810117210335Eckert & Ziegler Isotope Products, Inc.Eckert & Ziegler Isotope Products, Inc.JAR2022-12-07
00718175003800Bar PhantomBIODEX MEDICAL SYSTEMS, INC.JAR2018-02-15
00718175003985Bar PhantomBIODEX MEDICAL SYSTEMS, INC.JAR2018-02-15
00718175004395Bar PhantomBIODEX MEDICAL SYSTEMS, INC.JAR2018-02-15
00718175008164Bar PhantomBIODEX MEDICAL SYSTEMS, INC.JAR2018-02-15
00718175009352Bar PhantomBIODEX MEDICAL SYSTEMS, INC.JAR2018-02-15
00718175009550Bar PhantomBIODEX MEDICAL SYSTEMS, INC.JAR2018-02-15
00718175009871Bar PhantomBIODEX MEDICAL SYSTEMS, INC.JAR2018-02-15