FDA.reportPublic FDA data

Bravos Afterloader System

Primary DI
00816389027947
Brand
Bravos Afterloader System
Company
Varian Medical Systems Deutschland GmbH
Model
VG15000500
Catalog number
VG15000500
Device description
Bravos Afterloader System
Published
2018-11-16
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe

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
K181903000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K181903000BRAVOS Afterloader Family: BRAVOS Afterloader System, Transfer Guide Tubes, and Length Assessment DeviceVarian Medical Systems, Inc.2018-10-03JAQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00816389027947PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00816389027947008163890279478163890279470816389027947

GMDN Terms#

Term, Definition table
TermDefinition
Remote-afterloading brachytherapy systemAn 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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
332474605
Device count
1
Serial number
true
Manufacturing date on label
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
00816389029996Not used21282025-10-17
10810563022930Ovoid cervical stop set screw (pack of 8)AL07335000AL073350002025-05-21
00810563023022Titanium Allen wrenchAL07342000AL073420002025-05-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00816389028081MAASTRO Rectal Applicator Set, ΓΈ 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