FDA.reportPublic FDA data

Varian Brachytherapy Cleaning Caps, black (pack of 20)

Primary DI
10816389028217
Brand
Varian Brachytherapy Cleaning Caps, black (pack of 20)
Company
VARIAN MEDICAL SYSTEMS, INC.
Model
GM11003220
Catalog number
GM11003220
Published
2020-06-11
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
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
K141336000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K141336000SOURCE GUIDE TUBE WITH LOCKING MECHANISM FOR 113 MM NEEDLES, GAMMAMEDPLUSVarian Medical Systems, Inc.2014-08-06JAQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10816389028217PrimaryGS10
00816389028210Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081638902821710816389028217
00816389028210008163890282108163890282100816389028210

GMDN Terms#

Term, Definition table
TermDefinition
Tongue brachytherapy system applicator, remote-afterloadingA remote afterloading brachytherapy applicator specifically designed for use in radiation therapy treatments of the tongue or oral cavity. It is typically designed for temporary implantation within the tongue and/or the tissue surrounding the tongue and serves as a guide for computer-controlled placement and removal of single or multiple radioactive sources. This GMDN code includes a variety of applicators, e.g., hollow needles, tubes, or catheters, and their associated components.

Regulatory Flags#

DUNS number
009120817
Device count
20
DM exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00856100006493Respiratory Gating for Scanners2.12026-06-05
00816389028081MAASTRO Rectal Applicator Set, ø 26 mmGM11014100GM110141002026-06-02
00816389020191Applicator and Dilator for Proctoscope ø26 mmGM11014310GM110143102026-05-26
00816389020207Applicator and Dilator for Proctoscope ø30 mmGM11014410GM110144102026-05-26
00816389028098Applicator ø 20 mm, for Proctoscope ø 26 mmGM11014110GM110141102026-05-26
00816389028104Proctoscope ø 26 mmGM11014120GM110141202026-05-26
00816389028111Dilator for Proctoscope ø 26 mmGM11014130GM110141302026-05-26
00816389028128Illumination Adapter for Proctoscope ø 26 mmGM11014150GM110141502026-05-26
00816389028135Fixation ScrewGM11014160GM110141602026-05-26
00816389028142MAASTRO Rectal Applicator Set, ø 30 mmGM11014200GM110142002026-05-26
00816389028159Applicator ø 24 mm, for Proctoscope ø 30 mmGM11014210GM110142102026-05-26
00816389028166Proctoscope ø 30 mmGM11014220GM110142202026-05-26
00816389028173Dilator for Proctoscope ø 30 mmGM11014230GM110142302026-05-26
00816389028180Illumination Adapter for Proctoscope ø 30 mmGM11014250GM110142502026-05-26
00816389028999Targeting Window Applicator ø 20 mm, for Proctoscope ø 26 mmGM11014170GM110141702026-05-26
00816389029002Targeting Window Applicator ø 24 mm, for Proctoscope ø 30 mmGM11014270GM110142702026-05-26
00850800006074Vitesee5.0Vitesse 5.02024-11-01
00810563022032ISOLIS Cryoprobe 2.1mm (14 G) ISOLIS Cryoprobe, 15cm Length, EllipsoidalPC-2.1E2023-04-20
00810563022049ISOLIS Cryoprobe 2.1mm (14 G) ISOLIS Cryoprobe, 15cm Length, SphericalPC-2.1S2023-04-20
00810563022056ISOLIS Cryoprobe 2.1mm (14 G) ISOLIS Cryoprobe, 20cm Length, EllipsoidalPC-2.1EL2023-04-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00816389028081MAASTRO Rectal Applicator Set, ø 26 mmVARIAN MEDICAL SYSTEMS, INC.JAQ2026-06-02
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