Home GUDID 00863593000235 HDR MRI Lumen Marker
Primary DI 00863593000235
Brand HDR MRI Lumen Marker
Company C4 IMAGING, LLC
Model F-01-02-0001
Device description The HDR MRI Lumen Marker is a sealed high-density polyethylene (HDPE) tube containing a cobalt chloride N-Acetylcysteine saline solution. The HDPE tube is up to 350.0 mm in length and 1.0 mm in diameter, with the distal 19.0 mm of the tube accommodating a HDPE sealing plug. The distal end of the device is provided with an attached HDPE end-cap for handling. This end cap is approximately 3.0 mm in length. The HDR MRI Lumen Marker is an accessory to remote controlled high dose rate (HDR) radionuclide applicator systems and facilitates the identification of lumens within MRI compatible HDR brachytherapy applicators.
Published 2018-06-11
Public version status Update
Distribution status In Commercial Distribution
MRI safety MR Conditional
Rx true
OTC false
Sterile false
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 00863593000235 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 00863593000235 00863593000235 863593000235 0863593000235
GMDN Terms# Term, Definition table Term Definition Radiological image marker, implantable A device intended to be implanted within the body, either temporarily or permanently, to create identifying marks that can be seen on radiological images. It is typically in the form of a wire, needle, bead, clip, stent-like tube, washer or fluid, and used to locate and delineate a tumour, lesion, or other site of interest. It is made from materials compatible with the imaging system with which it is intended to be used [e.g., magnetic resonance imaging (MRI), x-ray, or nuclear medicine]; it may be intended for use during radiotherapy procedures. It is not an electromagnetic or optical spatial marker.
Regulatory Flags# DUNS number 036470387 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 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 00816389022294 Template pair, with 7 holes in equilateral triangles of 18mm VARIAN MEDICAL SYSTEMS, INC. JAQ 2016-09-23