FDA.reportPublic FDA data

Vaginal Applicator

Primary DI
08717213007734
Brand
Vaginal Applicator
Company
Nucletron B.V.
Model
084009-03
Device description
Cervical Stopper
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

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08717213007734PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08717213007734087172130077348717213007734

GMDN Terms#

Term, Definition table
TermDefinition
Vaginal brachytherapy system applicator, remote-afterloadingA remote afterloading brachytherapy applicator specifically designed for use in vaginal or transvaginal radiation therapy treatments. It is designed for temporary implantation within the body and serves as a guide for computer-controlled placement and removal of single or multiple radioactive sources in the vaginal area. This GMDN code includes a variety of applicators, e.g., hollow needles or tubes and catheters, and their associated components.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature5 Degrees Celsius35 Degrees Celsius

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
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 DI, Brand, Model table
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 DI, Brand, Company table
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