FDA.reportPublic FDA data

Connector for Universal Applicator, D=2.0mm (EasyClick 6F)

Primary DI
04065983001082
Brand
Connector for Universal Applicator, D=2.0mm (EasyClick 6F)
Company
BEBIG Medical GmbH
Model
01
Catalog number
LLS50-6F
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
04065983001082PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04065983001082040659830010824065983001082

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
04065983001068Easy Click Transfer Tube, D=3mm, L=1000mm03LAG10002024-04-26
04065983001075Easy Click Transfer Tube 6F, D=3mm, L=1000mm03LAG1000-6F2024-04-26
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