Home GUDID 00813787021096 Theragenics
Primary DI 00813787021096
Brand Theragenics
Company THERAGENICS CORPORATION
Model TG3432
Device description Gold Fiducial Marker Needles (18g) 1.0mm X 7.0mm (3)
Published 2015-09-28
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
OTC false
Sterile true
Single use true Product Codes# Code, Name table Code Name KXK Source, Brachytherapy, Radionuclide
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class KXK Source, Brachytherapy, Radionuclide Radiology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00813787021096 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 00813787021096 00813787021096 813787021096 0813787021096
GMDN Terms# Term, Definition table Term Definition Brachytherapy injection needle A sharp bevel-edged, hollow tubular metal instrument that is used to inject radionuclide into a body cavity or tissue as a source of nuclear radiation for cancer therapy (brachytherapy). The device may be pre-sterilized and preloaded, and may have a tip enhanced for ultrasound-guided implantation. This is a single-use device.
Sterilization Methods# Method table Method Ethylene Oxide
Regulatory Flags# DUNS number 114379522 Device count 1 DM exempt false Premarket exempt false HCT/P false Kit false Combination product false Lot or batch true Serial number false Manufacturing date on label false Expiration date on label true Donation ID number false Contains natural rubber latex true No natural rubber latex false Sterilization required before use true Other Devices From This Company# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published M936IIS4721 IsoSphere ISOAID, L.L.C. KXK 2026-05-12 M936IRLS15SSS9 Advantage I-125 ISOAID, L.L.C. KXK 2025-03-04 00850645007007 AOS Marker Seeds ALPHA-OMEGA SERVICES, INC. KXK 2024-07-15 B887MRTLS050515200 VISICOIL MR Twin Line Izi Medical Products, LLC KXK 2022-06-03 B887MRTLS075515180 VISICOIL MR Twin Line Izi Medical Products, LLC KXK 2022-06-03 M936IRLS20S9 Advantage I-125® ISOAID, L.L.C. KXK 2022-02-07 M936IRLS20SS9 Advantage I-125® ISOAID, L.L.C. KXK 2022-02-07 M936IRLS20SSS9 Advantage I-125® ISOAID, L.L.C. KXK 2022-02-07 00815212021336 2PK 0.8X3.0MM GOLD FIDUCIAL LOOSE Izi Medical Products, LLC KXK 2021-10-15 10801741184120 SourceLink™ Bard Brachytherapy, Inc. KXK 2020-08-06 10801741184137 SourceLink™ Bard Brachytherapy, Inc. KXK 2020-08-06 00813787021799 Theragenics THERAGENICS CORPORATION KXK 2020-07-15 00813787021805 Theragenics THERAGENICS CORPORATION KXK 2020-07-15 00813787021812 Theragenics THERAGENICS CORPORATION KXK 2020-07-15 00813787021829 Theragenics THERAGENICS CORPORATION KXK 2020-07-15 00813787021843 Theragenics THERAGENICS CORPORATION KXK 2020-07-15 00813787021850 Theragenics THERAGENICS CORPORATION KXK 2020-07-15 00813787021867 Theragenics THERAGENICS CORPORATION KXK 2020-07-15 00813787021836 Theragenics THERAGENICS CORPORATION KXK 2020-07-08 00853162006430 Stellar Medical STELLAR MEDICAL, LLC KXK 2020-05-28 00853162006447 Stellar Medical STELLAR MEDICAL, LLC KXK 2020-05-28 00853162006577 Stellar Medical STELLAR MEDICAL, LLC KXK 2020-05-28 00853162006607 Stellar Medical STELLAR MEDICAL, LLC KXK 2020-05-28 B887MRTL050415200 VISICOIL MR Twin Line Izi Medical Products, LLC KXK 2020-04-30 B887MRTL050415210 VISICOIL MR Twin Line Izi Medical Products, LLC KXK 2020-04-30 B887MRTL050820210 VISICOIL MR Twin Line Izi Medical Products, LLC KXK 2020-04-30 B887MRTL075415190 VISICOIL MR Twin Line Izi Medical Products, LLC KXK 2020-04-30 B887MRTL075820190 VISICOIL MR Twin Line Izi Medical Products, LLC KXK 2020-04-30 B887MRTLS075920180 VISICOIL MR Twin Line Izi Medical Products, LLC KXK 2020-04-30 B887PTTL050110210 VISICOIL MR Twin Line Izi Medical Products, LLC KXK 2020-04-30