FDA.reportPublic FDA data

Transfer Tube, D=3mm, L=1000mm, Green, Channel 1

Primary DI
04065983000993
Brand
Transfer Tube, D=3mm, L=1000mm, Green, Channel 1
Company
BEBIG Medical GmbH
Model
06
Catalog number
LAF1000-1
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
04065983000993PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04065983000993040659830009934065983000993

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
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
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
00816389028081MAASTRO Rectal Applicator Set, ø 26 mmVARIAN MEDICAL SYSTEMS, INC.JAQ2026-06-02
00816389027992Interstitial ovoid pair for 30mm spread, with fixation for guide tubesVARIAN MEDICAL SYSTEMS, INC.JAQ2025-05-21
00816389029460Intrauterine tandem, 15 degrees, 2 cm, CT/ MRVARIAN MEDICAL SYSTEMS, INC.JAQ2025-05-16
00816389029538Intrauterine tandem, 30 degrees, 8 cm, CT/ MRVARIAN MEDICAL SYSTEMS, INC.JAQ2025-05-16
00816389029637Ovoid, 40 mm, pair, CT/ MRVARIAN MEDICAL SYSTEMS, INC.JAQ2025-05-16
00816389029699Assembly module, CT/ MRVARIAN MEDICAL SYSTEMS, INC.JAQ2025-05-16
00816389029712Retractor, 30 mm, CT/ MRVARIAN MEDICAL SYSTEMS, INC.JAQ2025-05-16
00816389029743Retraction Nut CT/MRVARIAN MEDICAL SYSTEMS, INC.JAQ2025-05-16
00810563022551Needle collector pair for Titanium Fletcher-style applicatorVARIAN MEDICAL SYSTEMS, INC.JAQ2024-11-19
00816389020245Crook Prostate Template for 2.0 mm needlesVARIAN MEDICAL SYSTEMS, INC.JAQ2024-02-19
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
00816389029286Stainless steel needle 320mm, 18 gauge, trocar pointVARIAN MEDICAL SYSTEMS, INC.JAQ2023-05-05
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
00816389029255Stainless steel needle 113mm, 18 gauge, trocar pointVARIAN MEDICAL SYSTEMS, INC.JAQ2023-04-28
00816389028869VariSource VS2000 HDR Ir 192 Brachytherapy Sealed SourceVARIAN MEDICAL SYSTEMS, INC.JAQ2022-01-09
00816389027756Varian Titanium Applicator probe, 3mm dia x 320mm length, curved 15 degree, 50mmVARIAN MEDICAL SYSTEMS, INC.JAQ2019-11-06
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
08717213009318Esophageal ApplicatorNucletron B.V.JAQ2018-06-27
08717213007765Esophageal ApplicatorNucletron B.V.JAQ2018-06-20