Home GUDID 08717213030473 NA
Primary DI 08717213030473
Brand NA
Company Nucletron B.V.
Model 130025-06
Device description Compose/Delivery Element, Sterile
Published 2016-09-23
Public version status Update
Distribution status Not 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 JAQ System, applicator, radionuclide, remote-controlled
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class JAQ System, Applicator, Radionuclide, Remote-Controlled Radiology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 08717213030473 Package GS1 8 Not in Commercial Distribution 08717213023956 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 08717213030473 08717213030473 8717213030473 08717213023956 08717213023956 8717213023956
GMDN Terms# Term, Definition table Term Definition Remote-afterloading brachytherapy system An assembly of devices using a remotely-controlled radioactive source transport system designed to deliver a therapeutic or palliative radiation dose from a single source or source train to an anatomical region by placing the radioactive source(s) temporarily on or in the treatment site. A standard system consists of 1) a single radioactive source or source train in various forms; 2) a shielded vault to hold the sources when not used; 3) guide tubes/catheters to remotely direct the sources to the treatment site; 4) a remote-controlled mechanism to move the sources inside the guide tubes/catheters; 5) applicators; 6) computer treatment planning programs; and 7) an operator's console.
Regulatory Flags# DUNS number 415269930 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 true Expiration date on label true Donation ID number false Contains natural rubber latex false No natural rubber latex false Sterilization required before use false Other Devices From This Company# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 00841436125451 Classic Stepper CIVCO MEDICAL INSTRUMENTS CO., INC. JAQ 2026-07-23 00810563022551 Needle collector pair for Titanium Fletcher-style applicator VARIAN MEDICAL SYSTEMS, INC. JAQ 2024-11-19 00850645007007 AOS Marker Seeds ALPHA-OMEGA SERVICES, INC. JAQ 2024-07-15 00816389020245 Crook Prostate Template for 2.0 mm needles VARIAN MEDICAL SYSTEMS, INC. JAQ 2024-02-19 00810563021967 Plastic needle MR safe, 2.0 mm diameter x 200 mm length, with mandrin VARIAN MEDICAL SYSTEMS, INC. JAQ 2024-02-16 00810563021974 Plastic needle MR safe, 2.0 mm diameter x 320 mm length, with mandrin VARIAN MEDICAL SYSTEMS, INC. JAQ 2024-02-16 00810563021981 Plastic needle MR safe, 2.0 mm diameter x 320 mm length, blunt tip, with mandrin VARIAN MEDICAL SYSTEMS, INC. JAQ 2024-02-16 00810563022001 Mandrin for 200 mm length VARIAN MEDICAL SYSTEMS, INC. JAQ 2024-02-16 00810563022018 Mandrin for 320 mm length VARIAN MEDICAL SYSTEMS, INC. JAQ 2024-02-16 00810563022025 Plastic needle MR safe, 2.0 mm diameter x 113 mm length, with mandrin VARIAN MEDICAL SYSTEMS, INC. JAQ 2024-02-16 00810563021998 Mandrin for 113 mm length VARIAN MEDICAL SYSTEMS, INC. JAQ 2024-02-16 00816389022522 Mandrin for 200mm length Needle for Plastic Interstitial Needle VARIAN MEDICAL SYSTEMS, INC. JAQ 2021-02-02 00863593000235 HDR MRI Lumen Marker C4 IMAGING, LLC JAQ 2018-06-11 08717213043329 X-ray Catheters Nucletron B.V. JAQ 2016-09-25 08717213043336 X-ray Catheters Nucletron B.V. JAQ 2016-09-25 08717213043343 X-ray Catheters Nucletron B.V. JAQ 2016-09-25 08717213043688 X-ray Catheters Nucletron B.V. JAQ 2016-09-25 08717213043695 X-ray Catheters Nucletron B.V. JAQ 2016-09-25 08717213043701 X-ray Catheters Nucletron B.V. JAQ 2016-09-25 08717213043718 X-ray Catheters Nucletron B.V. JAQ 2016-09-25 08717213043725 X-ray Catheters Nucletron B.V. JAQ 2016-09-25 08717213043732 X-ray Catheters Nucletron B.V. JAQ 2016-09-25 08717213043749 X-ray Catheters Nucletron B.V. JAQ 2016-09-25 08717213043756 X-ray Catheters Nucletron B.V. JAQ 2016-09-25 08717213043763 X-ray Catheters Nucletron B.V. JAQ 2016-09-25 08717213021662 X-ray Catheters Nucletron B.V. JAQ 2016-09-25 08717213028463 X-ray Catheters Nucletron B.V. JAQ 2016-09-25 10816389027296 Universal fixation button, radiopaque, pack of 100, non-sterile VARIAN MEDICAL SYSTEMS, INC. JAQ 2016-09-23 00816389021747 Central clamping mechanism VARIAN MEDICAL SYSTEMS, INC. JAQ 2016-09-23 00816389021778 Intrauterine probe with stop, 30 degrees angle, length 80mm VARIAN MEDICAL SYSTEMS, INC. JAQ 2016-09-23
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