FDA.reportPublic FDA data

Cs-137 Tube Source

Primary DI
00858589006001
Brand
Cs-137 Tube Source
Company
Eckert & Ziegler Isotope Products, Inc.
Model
67-6525
Catalog number
67-6525
Device description
Cs-137 62.5 mCi, sealed source
Published
2016-03-29
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
KXKSource, Brachytherapy, Radionuclide

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KXKSource, Brachytherapy, RadionuclideRadiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00858589006001PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00858589006001008585890060018585890060010858589006001

GMDN Terms#

Term, Definition table
TermDefinition
Manual brachytherapy source, temporary placementA device that is a naturally-occurring, accelerator- or reactor-produced radioactive isotope in a form that is intended for temporary placement in the body and removal after a specified treatment time. It is used in brachytherapy applications that require direct manual or endoscopically-guided placement and removal. Manually inserted sources intended for temporary placement come in a variety of forms, e.g., encapsulated, sealed, plated, foil or embedded sources. It can be inserted directly into the patient or be implanted using catheters or applicators and may take the form of needles, spheres, ovoids, seeds, wires or liquids included in the cuffed portion of a catheter.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
041668633
Device count
1
Premarket exempt
true
Serial number
true
Sterilization required before use
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

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Primary DI, Brand, Company table
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M936IRLS20S9Advantage I-125®ISOAID, L.L.C.KXK2022-02-07
M936IRLS20SS9Advantage I-125®ISOAID, L.L.C.KXK2022-02-07
008152120213362PK 0.8X3.0MM GOLD FIDUCIAL LOOSEIzi Medical Products, LLCKXK2021-10-15
10801741184120SourceLink™Bard Brachytherapy, Inc.KXK2020-08-06
10801741184137SourceLink™Bard Brachytherapy, Inc.KXK2020-08-06
00813787021799TheragenicsTHERAGENICS CORPORATIONKXK2020-07-15
00813787021805TheragenicsTHERAGENICS CORPORATIONKXK2020-07-15
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00813787021829TheragenicsTHERAGENICS CORPORATIONKXK2020-07-15
00813787021843TheragenicsTHERAGENICS CORPORATIONKXK2020-07-15
00813787021850TheragenicsTHERAGENICS CORPORATIONKXK2020-07-15
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00813787021836TheragenicsTHERAGENICS CORPORATIONKXK2020-07-08
00853162006430Stellar MedicalSTELLAR MEDICAL, LLCKXK2020-05-28
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00853162006607Stellar MedicalSTELLAR MEDICAL, LLCKXK2020-05-28
B887MRTL050415200VISICOIL MR Twin LineIzi Medical Products, LLCKXK2020-04-30
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B887MRTL050820210VISICOIL MR Twin LineIzi Medical Products, LLCKXK2020-04-30
B887MRTL075415190VISICOIL MR Twin LineIzi Medical Products, LLCKXK2020-04-30
B887MRTL075820190VISICOIL MR Twin LineIzi Medical Products, LLCKXK2020-04-30
B887MRTLS075920180VISICOIL MR Twin LineIzi Medical Products, LLCKXK2020-04-30
B887PTTL050110210VISICOIL MR Twin LineIzi Medical Products, LLCKXK2020-04-30
B887TL050215200VISICOILIzi Medical Products, LLCKXK2020-04-30