FDA.reportPublic FDA data

Not used

Primary DI
00816389029996
Brand
Not used
Company
Varian Medical Systems Deutschland GmbH
Model
2128
Published
2025-10-17
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
JAQSystem, applicator, radionuclide, remote-controlled

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JAQSystem, Applicator, Radionuclide, Remote-ControlledRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K952913000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K952913000APPLICATORS FOR VARIAN VARISOURCE REMOTE HIGH SOES RATE AFTERLOADERVarian Assoc., Inc.1995-11-22JAQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00816389029996PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00816389029996008163890299968163890299960816389029996

GMDN Terms#

Term, Definition table
TermDefinition
General-purpose brachytherapy system applicator, remote-afterloadingA general-purpose remote-afterloading brachytherapy applicator intended to be used to facilitate the delivery of radiation therapy treatments in a range of anatomical regions (e.g., liver, kidneys, lungs, gastrointestinal tract). It is designed for temporary introduction into the body and functions as a guide for computer-controlled placement and removal of single or multiple radioactive sources in a treatment area. This device includes a variety of applicators (e.g., hollow needle, tube, catheter), and their associated components [e.g., introducer sheath, guidewire].

Regulatory Flags#

DUNS number
332474605
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810563021967Plastic needle MR safe, 2.0 mm diameter x 200 mm length, with mandrinGM11014710GM110147102024-02-16
00810563021974Plastic needle MR safe, 2.0 mm diameter x 320 mm length, with mandrinGM11014720GM110147202024-02-16
00810563021981Plastic needle MR safe, 2.0 mm diameter x 320 mm length, blunt tip, with mandrinGM11014730GM110147302024-02-16
00810563022001Mandrin for 200 mm lengthGM11010450GM110104502024-02-16
00810563022018Mandrin for 320 mm lengthGM11010470GM110104702024-02-16
00810563022025Plastic needle MR safe, 2.0 mm diameter x 113 mm length, with mandrinGM11014700GM110147002024-02-16
00810563021998Mandrin for 113 mm lengthGM11010390GM110103902024-02-16
00810563022100Universal Endometrial Applicator SetGM11009840GM110098402023-04-16
00816389020405Afterloader Basic Device GammaMedplus 3/24,115V, Series iXGM84000290GM840002902016-09-16
00816389020412Afterloader Basic Device GammaMedplus 3/24,230V, Series iXGM84000300GM840003002016-09-16
00816389027329Afterloader Basic Device GammaMedplus 3/24, 127V,Series iXGM84000560GM840005602016-09-16
00816389029934Not used21252025-10-17
00816389029941Not used11262025-10-17
00816389029958Not used21262025-10-17
00816389029965Not used11272025-10-17
00816389029972Not used21272025-10-17
00816389029989Not used11282025-10-17
10810563022930Ovoid cervical stop set screw (pack of 8)AL07335000AL073350002025-05-21
00810563023022Titanium Allen wrenchAL07342000AL073420002025-05-21
00816389027961Interstitial mini ovoid pair, with fixation for guide tubesGM11013420GM110134202025-05-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08717213014305NANucletron B.V.JAQ2019-02-02
08717213008472Shielded Cylindrical ApplicatorNucletron B.V.JAQ2018-07-11
08717213008892NANucletron B.V.JAQ2018-07-11
08717213008908NANucletron B.V.JAQ2018-07-11
08717213008915NANucletron B.V.JAQ2018-07-11
08717213009578Miami Vaginal ApplicatorNucletron B.V.JAQ2018-07-11
08717213009585Miami Vaginal ApplicatorNucletron B.V.JAQ2018-07-11
08717213009646Miami Vaginal ApplicatorNucletron B.V.JAQ2018-07-11
08717213007772Fletcher Williamson ApplicatorNucletron B.V.JAQ2018-07-06
08717213007796Fletcher Williamson ApplicatorNucletron B.V.JAQ2018-07-06
08717213007826Fletcher Williamson ApplicatorNucletron B.V.JAQ2018-07-06
08717213009660Fletcher Williamson ApplicatorNucletron B.V.JAQ2018-07-06
08717213009677Fletcher Williamson ApplicatorNucletron B.V.JAQ2018-07-06
08717213009691Fletcher Williamson ApplicatorNucletron B.V.JAQ2018-07-06
08717213010000Flexible Implant TubesNucletron B.V.JAQ2018-07-06
08717213010024Flexible Implant TubesNucletron B.V.JAQ2018-07-06
08717213009318Esophageal ApplicatorNucletron B.V.JAQ2018-06-27
08717213010666Flexible Implant TubesNucletron B.V.JAQ2018-06-27
08717213007765Esophageal ApplicatorNucletron B.V.JAQ2018-06-20
08717213009042Esophageal ApplicatorNucletron B.V.JAQ2018-06-20
08717213009059Esophageal ApplicatorNucletron B.V.JAQ2018-06-20
08717213013926Vaginal CT/MR ApplicatorNucletron B.V.JAQ2018-06-20
08717213008274MicroSelectron DigitalNucletron B.V.JAQ2018-06-14
08717213014022Standard CT/MR ApplicatorNucletron B.V.JAQ2018-06-09
08717213014039Standard CT/MR ApplicatorNucletron B.V.JAQ2018-06-09
08717213014145Ring CT/MR ApplicatorNucletron B.V.JAQ2018-06-09
08717213014152Ring CT/MR ApplicatorNucletron B.V.JAQ2018-06-09
08717213014169Ring CT/MR ApplicatorNucletron B.V.JAQ2018-06-09
08717213014206Ring CT/MR ApplicatorNucletron B.V.JAQ2018-06-09
08717213014213Ring CT/MR ApplicatorNucletron B.V.JAQ2018-06-09