Home GUDID 00817740020973 BIONIX RADIATION THERAPY
Primary DI 00817740020973
Brand BIONIX RADIATION THERAPY
Company Bionix Radiation Therapy, LLC
Model AR-2-35x80
Catalog number AR-2-35x80
Device description ANORECTAL APPLICATOR
Published 2017-04-25
Public version status Update
Distribution status Not in Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
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 00817740020973 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 00817740020973 00817740020973 817740020973 0817740020973
GMDN Terms# Term, Definition table Term Definition Anorectal brachytherapy system applicator, remote-afterloading A remote afterloading brachytherapy applicator specifically designed for use in radiation therapy treatments of the rectum and/or anus. It is designed for temporary implantation within the rectum and/or anus and serve as a guide for computer-controlled placement and removal of single or multiple radioactive sources. This GMDN code includes a variety of anorectal applicators, e.g., hollow needles, tubes, or catheters, and their associated components.
Device Sizes# Type, Value, Unit table Type Value Unit Device Size Text, specify 0 Device Size Text, specify 0 Length 80 Millimeter Outer Diameter 35 Millimeter
Storage And Handling# Type, Low, High table Type Low High Condition Special Storage Condition, Specify 0 0 STORE IN A COOL, DRY ENVIRONMENT
Sterilization Methods# Method table Method Ethylene Oxide
Regulatory Flags# DUNS number 080397923 Device count 1 DM exempt true Lot or batch true Expiration date on label true 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 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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