FDA.reportPublic FDA data

Source Exchange Tube for Container T41, Ir-192

Primary DI
04049223106058
Brand
Source Exchange Tube for Container T41, Ir-192
Company
Eckert & Ziegler BEBIG GmbH
Model
LAZ20-04
Catalog number
LAZ20-04
Published
2016-10-05
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

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
04049223106058PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04049223106058040492231060584049223106058

GMDN Terms#

Term, Definition table
TermDefinition
Brachytherapy system remote afterloading source safeA component of a remote afterloading brachytherapy system consisting of a shielded vault, and associated source retraction and extrusion mechanisms, alarms, and related mechanical, electronic and software controls, used to shield the brachytherapy sources in order to protect system operators, brachytherapy patients and others from the continuous emissions of the radioactive brachytherapy source(s) when they are not in use.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+4930941084130info@bebig.com

Regulatory Flags#

DUNS number
331080432
Device count
1
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04049223114527CT/MR Obturator for Plastic Needle, L= 300 mm (à 1 pc)LLH02-300LLH02-3002016-10-10
04049223104047Opening Forceps for Holding DiscsLAH05-03#05LAH05-032020-12-21
04049223132088SagiPlan® 2.x Software1374-0600#031374-06002020-07-01
04049223132613Universal Applicator incl. plug, D=3mm, L=1400mm (non sterile)LAA1400-GYN#02LAA1400-GYN2020-03-31
04049223133634Universal Applicator, marked, D=2mm, L=1200mm (sterile)LLA1200-20#04LLA1200-202020-03-31
04049223101077Flexible Catheter Single Leader, D=1.65mm, L=300mmLLA300-F#02-SPLLA300-F2016-10-06
04049223101169Plastic Needle, D=1.65mm, L=150mm, 16GLLA150-KB#02-SPLLA150-KB2016-10-06
04049223101176Plastic Needle, D=1.65mm, L=200mm, 16GLLA200-KB#02-SPLLA200-KB2016-10-06
04049223101183Plastic Needle, D=1.65mm, L=300mm, 16GLLA300-KB#02-SPLLA300-KB2016-10-06
04049223101190Cutter for flexible CathetersLAH06-01#03LAH06-012016-10-05
04049223101206CT/MR Intrauterine Tube straight, thin, D=3.5mmLCT01-01#03LCT01-012016-10-07
04049223101213CT/MR Intrauterine Tube 15°, thin, D=3.5mm, IUL=25mmLCT02-01#03LCT02-012016-10-07
04049223101220CT/MR Intrauterine Tube 20°, thin, D=3.5mm, IUL=30mmLCT03-01#03LCT03-012016-10-07
04049223101237CT/MR Intrauterine Tube 25°, thin, D=3.5mm, IUL=35mmLCT04-01#03LCT04-012016-10-07
04049223101244CT/MR Intrauterine Tube 40°, thin, D=3.5mm, IUL=35mmLCT05-01#03LCT05-012016-10-07
04049223101251CT/MR Intrauterine Tube 30°, thin, D=3.5mm, IUL=65mmLCT06-01#03LCT06-012016-10-07
04049223101770CT/MR Fletcher Ovoid Tubes right and leftLCT82-02#03LCT82-022016-10-07
04049223102722Vaginal Cylinder with variable length, D=20mm, L=120mmLAZ07-01#04LAZ07-012016-10-07
04049223102739CT/MR-Vag. Cylinder with variable length D=20mm L=120mmLCZ07-01#04LCZ07-012016-10-07
04049223102784Channel Coding for Needles and Catheters (Channel 1)LLZ03-01LLZ03-012016-10-10

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