FDA.reportPublic FDA data

Clamping adapter for 5 Fr bronchial catheter, GammaMedplus

Primary DI
00816389021563
Brand
Clamping adapter for 5 Fr bronchial catheter, GammaMedplus
Company
Varian Medical Systems Deutschland GmbH
Model
GM11000470
Catalog number
GM11000470
Published
2016-09-22
Public version status
Update
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
K151022000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K151022000Intraluminal Applicator SetVarian Medical Systems, Inc.2015-12-17JAQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00816389021563PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00816389021563008163890215638163890215630816389021563

GMDN Terms#

Term, Definition table
TermDefinition
Brachytherapy system remote afterloading source transfer tubeA tube or hose-like catheter with connectors at both ends used to interface the brachytherapy applicator to the remote afterloading system. The transfer tube, when attached to the applicator and the afterloading system, provides a continuous closed passage that allows for moving either a radioactive source(s) and/or positioning markers from the shielded source storage compartment of the remote afterloading brachytherapy system into appropriate positions within a brachytherapy applicator that has been positioned at a location either on the surface of, or within, the patient.

Sterilization Methods#

Method table
Method

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
00810563021998Mandrin for 113 mm lengthGM11010390GM110103902024-02-16
00810563022100Universal Endometrial Applicator SetGM11009840GM110098402023-04-16
00816389020405Afterloader Basic Device GammaMedplus 3/24,115V, Series iXGM84000290GM840002902016-09-16
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
00816389027961Interstitial mini ovoid pair, with fixation for guide tubesGM11013420GM110134202025-05-21
00816389027978Interstitial ovoid pair for 20mm spread, with fixation for guide tubesGM11013430GM110134302025-05-21

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
00816389029460Intrauterine tandem, 15 degrees, 2 cm, CT/ MRVARIAN MEDICAL SYSTEMS, INC.JAQ2025-05-16
00816389029637Ovoid, 40 mm, pair, CT/ MRVARIAN MEDICAL SYSTEMS, INC.JAQ2025-05-16
00816389029712Retractor, 30 mm, CT/ MRVARIAN MEDICAL SYSTEMS, INC.JAQ2025-05-16
00816389020276Crook Prostate Template for 17 gauge (1.47 mm) needlesVARIAN MEDICAL SYSTEMS, INC.JAQ2024-02-19
00810563022025Plastic needle MR safe, 2.0 mm diameter x 113 mm length, with mandrinVARIAN MEDICAL SYSTEMS, INC.JAQ2024-02-16
00816389029217Stainless steel needle 113mm, 17 gauge, trocar pointVARIAN MEDICAL SYSTEMS, INC.JAQ2023-04-28
00816389029224Stainless steel needle 200mm, 17 gauge, trocar pointVARIAN MEDICAL SYSTEMS, INC.JAQ2023-04-28
00816389028869VariSource VS2000 HDR Ir 192 Brachytherapy Sealed SourceVARIAN MEDICAL SYSTEMS, INC.JAQ2022-01-09
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