FDA.report

Leipzig Applicator

Primary DI
08717213009196
Brand
Leipzig Applicator
Company
Nucletron B.V.
Model
085041-02
Device description
Leipzig Applicator, Ø 10 mm, horizontal
Published
2019-09-18
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
JAQSystem, applicator, radionuclide, remote-controlled

Product Code Classifications

CodeDeviceSpecialtyClass
JAQSystem, Applicator, Radionuclide, Remote-ControlledRadiology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
08717213009196PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
08717213009196087172130091968717213009196

GMDN Terms

TermDefinition
General-purpose brachytherapy system applicator, remote-afterloadingA general-purpose remote-afterloading brachytherapy applicator intended to be used to facilitate the delivery of radiation therapy treatments in a range of anatomical regions (e.g., liver, kidneys, lungs, gastrointestinal tract). It is designed for temporary introduction into the body and functions as a guide for computer-controlled placement and removal of single or multiple radioactive sources in a treatment area. This device includes a variety of applicators (e.g., hollow needle, tube, catheter), and their associated components [e.g., introducer sheath, guidewire].

Device Sizes

TypeValueUnit
Outer Diameter10Millimeter

Storage And Handling

TypeLowHighCondition
Storage Environment Humidity0 Percent (%) Relative Humidity90 Percent (%) Relative Humidity

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
+1(770)300-9725info.america@elekta.com

Regulatory Flags

DUNS number
415269930
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company

Primary DIBrandModelCatalogPublished
08717213058118NA1707302025-11-13
08717213060722Elekta Freiburg Flap592976P01-022025-02-18
08717213057203Smit Sleeve189565-012024-07-05
08717213057258Smit Sleeve129117-002024-07-05
08717213054363Luneray110560-012022-11-15
08717213054370Luneray110561-012022-11-15
08717213054387Luneray110562-012022-11-15
08717213054394Luneray110563-012022-11-07
08717213057760Esteya187001SE2022-08-16
08717213056947NA189714P01-032022-06-30
08717213008991X-ray Catheters084880-002016-09-10
08717213009387X-ray Catheters085075-012016-09-10
08717213010192X-ray Catheters089082-012016-09-10
08717213010208X-ray Catheters089083-012016-09-10
08717213010253X-ray Catheters089089-012016-09-10
08717213010260X-ray Catheters089090-012016-09-10
08717213011120X-ray Catheters089420-012016-09-10
08717213014398X-ray Catheters101065-022016-09-10
08717213020474X-ray Catheters189850-002016-09-10
08717213020481X-ray Catheters189851-002016-09-10

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
00816389020191Applicator and Dilator for Proctoscope ø26 mmVARIAN MEDICAL SYSTEMS, INC.JAQ2026-05-26
00816389020207Applicator and Dilator for Proctoscope ø30 mmVARIAN MEDICAL SYSTEMS, INC.JAQ2026-05-26
00816389028098Applicator ø 20 mm, for Proctoscope ø 26 mmVARIAN MEDICAL SYSTEMS, INC.JAQ2026-05-26
00816389028104Proctoscope ø 26 mmVARIAN MEDICAL SYSTEMS, INC.JAQ2026-05-26
00816389028111Dilator for Proctoscope ø 26 mmVARIAN MEDICAL SYSTEMS, INC.JAQ2026-05-26
00816389028128Illumination Adapter for Proctoscope ø 26 mmVARIAN MEDICAL SYSTEMS, INC.JAQ2026-05-26
00816389028135Fixation ScrewVARIAN MEDICAL SYSTEMS, INC.JAQ2026-05-26
00816389028142MAASTRO Rectal Applicator Set, ø 30 mmVARIAN MEDICAL SYSTEMS, INC.JAQ2026-05-26
00816389028159Applicator ø 24 mm, for Proctoscope ø 30 mmVARIAN MEDICAL SYSTEMS, INC.JAQ2026-05-26
00816389028166Proctoscope ø 30 mmVARIAN MEDICAL SYSTEMS, INC.JAQ2026-05-26
00816389028173Dilator for Proctoscope ø 30 mmVARIAN MEDICAL SYSTEMS, INC.JAQ2026-05-26
00816389028180Illumination Adapter for Proctoscope ø 30 mmVARIAN MEDICAL SYSTEMS, INC.JAQ2026-05-26
00816389028999Targeting Window Applicator ø 20 mm, for Proctoscope ø 26 mmVARIAN MEDICAL SYSTEMS, INC.JAQ2026-05-26
00816389029002Targeting Window Applicator ø 24 mm, for Proctoscope ø 30 mmVARIAN MEDICAL SYSTEMS, INC.JAQ2026-05-26
00810563022629Guiding tube 60 degrees ring for central needleVARIAN MEDICAL SYSTEMS, INC.JAQ2025-11-25
00816389028937Guided Aarhus Applicator SetVARIAN MEDICAL SYSTEMS, INC.JAQ2025-11-25
00816389028944Guided Aarhus vaginal template 60 degrees,ø 28 mmVARIAN MEDICAL SYSTEMS, INC.JAQ2025-11-25
00816389028951Guided Aarhus vaginal template 60 degrees, ø 32 mmVARIAN MEDICAL SYSTEMS, INC.JAQ2025-11-25
00816389028968Guided Aarhus vaginal template 60 degrees, ø 36 mmVARIAN MEDICAL SYSTEMS, INC.JAQ2025-11-25
00816389028975Guide tube collector for up to 7 needlesVARIAN MEDICAL SYSTEMS, INC.JAQ2025-11-25
00816389028982Guide tube collector for up to 11 needlesVARIAN MEDICAL SYSTEMS, INC.JAQ2025-11-25
00810563022957Titanium Flexible Geometry FSD Applicator SetVARIAN MEDICAL SYSTEMS, INC.JAQ2025-05-22
00810563022995Ovoid pair, mini ø 16 mmVARIAN MEDICAL SYSTEMS, INC.JAQ2025-05-22
00810563023008Ovoid mini Ø16 mm LeftVARIAN MEDICAL SYSTEMS, INC.JAQ2025-05-22
00810563023015Ovoid mini Ø16 mm RightVARIAN MEDICAL SYSTEMS, INC.JAQ2025-05-22
00810563023022Titanium Allen wrenchVarian Medical Systems Deutschland GmbHJAQ2025-05-21
00816389027961Interstitial mini ovoid pair, with fixation for guide tubesVarian Medical Systems Deutschland GmbHJAQ2025-05-21
00816389027978Interstitial ovoid pair for 20mm spread, with fixation for guide tubesVarian Medical Systems Deutschland GmbHJAQ2025-05-21
00816389027985Interstitial ovoid pair for 25mm spread, with fixation for guide tubesVarian Medical Systems Deutschland GmbHJAQ2025-05-21
00816389027992Interstitial ovoid pair for 30mm spread, with fixation for guide tubesVarian Medical Systems Deutschland GmbHJAQ2025-05-21