Home GUDID 00816389020412 Afterloader Basic Device GammaMedplus 3/24,230V, Series iX
Primary DI 00816389020412
Brand Afterloader Basic Device GammaMedplus 3/24,230V, Series iX
Company VARIAN MEDICAL SYSTEMS, INC.
Model GM84000300
Catalog number GM84000300
Published 2016-09-16
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx false
OTC false
Sterile false
Single use false 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 00816389020412 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 00816389020412 00816389020412 816389020412 0816389020412
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 009120817 Device count 1 DM exempt false Premarket exempt false HCT/P false Kit false Combination product false Lot or batch false Serial number true Manufacturing date on label true Expiration date on label false Donation ID number false Contains natural rubber latex false No natural rubber latex false Sterilization required before use false Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 00810563022025 Plastic needle MR safe, 2.0 mm diameter x 113 mm length, with mandrin GM11014700 GM11014700 2024-02-16 00810563022322 Temperature Sensor Probe, 18G x 20cm ABL-18TP20 2024-08-09 00816389029460 Intrauterine tandem, 15 degrees, 2 cm, CT/ MR GM11012510 GM11012510 2025-05-16 00816389029637 Ovoid, 40 mm, pair, CT/ MR GM11012750 GM11012750 2025-05-16 00816389029712 Retractor, 30 mm, CT/ MR GM11012930 GM11012930 2025-05-16 00816389020276 Crook Prostate Template for 17 gauge (1.47 mm) needles GM11012260 GM11012260 2024-02-19 00810563020953 8mm Cryoprobe DP35-0215-101 CRYO-48-F 2022-02-18 00810563020984 MicroThermX Microwave Ablation System 20-17222-001 MTX-180 2022-02-18 00810563020991 MicroThermX Microwave Ablation System 20-17222-101 MTX180-T2 2022-02-18 00816389028906 2.4mm V-Probe™ Cryoprobe DP35-0900-101 CVA2400 2022-02-18 00816389028920 2.4mm V-Probe™ Cryoprobe Right Angle DP35-0902-108 CVA2400RA 2022-02-18 00816389028869 VariSource VS2000 HDR Ir 192 Brachytherapy Sealed Source AL09400000 AL09400000 2022-01-09 00856104006000 Varian Treatment 13.0 2016-09-16 00856545006027 VariSource iX 1.2 AL19004-000 2016-09-16 00856545006034 VariSource iX(t) 1.2 AL19004-001 2016-09-16 00816389020986 TANDEM ROTATE & SLIDE BLOCK (CT/MR FSD) AL10715008 AL10715008 2016-09-19 00816389021686 Intrauterine probe with stopper, angle 30 degrees, length 50 mm GM11000790 GM11000790 2016-09-23 00816389021785 Mini-colpostats, pair GM11000900 GM11000900 2016-09-19 00816389022164 Applicator probe 6/3 mm diameter, curved 15 degrees, length 320 mm GM11002230 2016-09-22 00816389022386 Implant needle, 120 mm, 1.7 mm diameter, curved GM11002930 GM11002930 2016-09-23
Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 00816389028081 MAASTRO Rectal Applicator Set, ø 26 mm VARIAN MEDICAL SYSTEMS, INC. JAQ 2026-06-02 00816389029460 Intrauterine tandem, 15 degrees, 2 cm, CT/ MR VARIAN MEDICAL SYSTEMS, INC. JAQ 2025-05-16 00816389029637 Ovoid, 40 mm, pair, CT/ MR VARIAN MEDICAL SYSTEMS, INC. JAQ 2025-05-16 00816389029712 Retractor, 30 mm, CT/ MR VARIAN MEDICAL SYSTEMS, INC. JAQ 2025-05-16 00816389020276 Crook Prostate Template for 17 gauge (1.47 mm) needles VARIAN MEDICAL SYSTEMS, INC. JAQ 2024-02-19 00810563022025 Plastic needle MR safe, 2.0 mm diameter x 113 mm length, with mandrin VARIAN MEDICAL SYSTEMS, INC. JAQ 2024-02-16 00816389029217 Stainless steel needle 113mm, 17 gauge, trocar point VARIAN MEDICAL SYSTEMS, INC. JAQ 2023-04-28 00816389029224 Stainless steel needle 200mm, 17 gauge, trocar point VARIAN MEDICAL SYSTEMS, INC. JAQ 2023-04-28 00816389028869 VariSource VS2000 HDR Ir 192 Brachytherapy Sealed Source VARIAN MEDICAL SYSTEMS, INC. JAQ 2022-01-09 08717213014305 NA Nucletron B.V. JAQ 2019-02-02 08717213008472 Shielded Cylindrical Applicator Nucletron B.V. JAQ 2018-07-11 08717213008892 NA Nucletron B.V. JAQ 2018-07-11 08717213008908 NA Nucletron B.V. JAQ 2018-07-11 08717213008915 NA Nucletron B.V. JAQ 2018-07-11 08717213009578 Miami Vaginal Applicator Nucletron B.V. JAQ 2018-07-11 08717213009585 Miami Vaginal Applicator Nucletron B.V. JAQ 2018-07-11 08717213009646 Miami Vaginal Applicator Nucletron B.V. JAQ 2018-07-11 08717213007772 Fletcher Williamson Applicator Nucletron B.V. JAQ 2018-07-06 08717213007796 Fletcher Williamson Applicator Nucletron B.V. JAQ 2018-07-06 08717213007826 Fletcher Williamson Applicator Nucletron B.V. JAQ 2018-07-06 08717213009660 Fletcher Williamson Applicator Nucletron B.V. JAQ 2018-07-06 08717213009677 Fletcher Williamson Applicator Nucletron B.V. JAQ 2018-07-06 08717213009691 Fletcher Williamson Applicator Nucletron B.V. JAQ 2018-07-06 08717213010000 Flexible Implant Tubes Nucletron B.V. JAQ 2018-07-06 08717213010024 Flexible Implant Tubes Nucletron B.V. JAQ 2018-07-06 08717213009318 Esophageal Applicator Nucletron B.V. JAQ 2018-06-27 08717213010666 Flexible Implant Tubes Nucletron B.V. JAQ 2018-06-27 08717213007765 Esophageal Applicator Nucletron B.V. JAQ 2018-06-20 08717213009042 Esophageal Applicator Nucletron B.V. JAQ 2018-06-20 08717213009059 Esophageal Applicator Nucletron B.V. JAQ 2018-06-20