FDA.reportPublic FDA data

Easy Click Transfer Tube, D=3mm, L=1000mm

Primary DI
04065983001068
Brand
Easy Click Transfer Tube, D=3mm, L=1000mm
Company
BEBIG Medical GmbH
Model
03
Catalog number
LAG1000
Device description
The Transfer Tubes and Couplings are intended for connecting HDR applicators to the treatment delivery unit (TDU).
Published
2024-04-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
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
K142986000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K142986000SagiNovaEckert & Ziegler Bebig GmbH2015-04-17JAQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04065983001068PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04065983001068040659830010684065983001068

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
343363100
Device count
1
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04065983002850Disposable steel needle, 17G, L=200mm05LLA210-S2024-09-18
04065983000986Transfer Tube, D=3mm, L=1000mm06LAF10002024-04-26
04065983000993Transfer Tube, D=3mm, L=1000mm, Green, Channel 106LAF1000-12024-04-26
04065983001006Transfer Tube, D=3mm, L=1000mm, Yellow, Channel 206LAF1000-22024-04-26
04065983001013Transfer Tube, D=3mm, L=1000mm, Blue, Channel 306LAF1000-32024-04-26
04065983001020Transfer Tube, D=3mm, L=1000mm, T-connector01LAF1000-T2024-04-26
04065983001037Transfer Tube, D=3mm, L=1000mm, Green, Channel 1, T-connector01LAF1000-1-T2024-04-26
04065983001044Transfer Tube, D=3mm, L=1000mm, Yellow, Channel 2, T-connector01LAF1000-2-T2024-04-26
04065983001051Transfer Tube, D=3mm, L=1000mm, Blue, Channel 3, T-connector01LAF1000-3-T2024-04-26
04065983001075Easy Click Transfer Tube 6F, D=3mm, L=1000mm03LAG1000-6F2024-04-26
04065983001082Connector for Universal Applicator, D=2.0mm (EasyClick 6F)01LLS50-6F2024-04-26
04065983000023SagiNova® 25 channels, for Co-60 and Ir-192061321-02012024-01-24
04065983000030SagiNova® Ir 25 channels, for Ir-192 only061321-02022024-01-24
04065983000016SagiPlan®061374-06002023-11-28
04065983000047SagiPlan® with prostate module061374-06102023-11-28

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