FDA.report

Vaginal Applicator

Primary DI
08717213007703
Brand
Vaginal Applicator
Company
Nucletron B.V.
Model
084004-00
Device description
Intrauterine Tube, L= 60 mm, angle 30°
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
08717213007703PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
08717213007703087172130077038717213007703

GMDN Terms

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.

Device Sizes

TypeValueUnit
Length60Millimeter

Storage And Handling

TypeLowHighCondition
Storage Environment Temperature5 Degrees Celsius35 Degrees Celsius

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
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
00810563022933Ovoid \ cervical stop set screw (pack of 8)Varian Medical Systems Deutschland GmbHJAQ2025-05-21
00810563022612Disassembly Pin, CT/ MRVarian Medical Systems Deutschland GmbHJAQ2025-05-16
00816389029439CT/ MR Tandem and Ovoid Set (CTO)Varian Medical Systems Deutschland GmbHJAQ2025-05-16
00816389029446Colpostat probe, left, CT/ MRVarian Medical Systems Deutschland GmbHJAQ2025-05-16
00816389029453Colpostat probe, right, CT/ MRVarian Medical Systems Deutschland GmbHJAQ2025-05-16
00816389029460Intrauterine tandem, 15 degrees, 2 cm, CT/ MRVarian Medical Systems Deutschland GmbHJAQ2025-05-16
00816389029477Intrauterine tandem, 15 degrees, 4 cm, CT/ MRVarian Medical Systems Deutschland GmbHJAQ2025-05-16
00816389029484Intrauterine tandem, 15 degrees, 6 cm, CT/ MRVarian Medical Systems Deutschland GmbHJAQ2025-05-16
00816389029491Intrauterine tandem, 15 degrees, 8 cm, CT/ MRVarian Medical Systems Deutschland GmbHJAQ2025-05-16
00816389029507Intrauterine tandem, 30 degrees, 2 cm, CT/ MRVarian Medical Systems Deutschland GmbHJAQ2025-05-16
00816389029514Intrauterine tandem, 30 degrees, 4 cm, CT/ MRVarian Medical Systems Deutschland GmbHJAQ2025-05-16
00816389029521Intrauterine tandem, 30 degrees, 6 cm, CT/ MRVarian Medical Systems Deutschland GmbHJAQ2025-05-16
00816389029538Intrauterine tandem, 30 degrees, 8 cm, CT/ MRVarian Medical Systems Deutschland GmbHJAQ2025-05-16
00816389029545Intrauterine tandem, 45 degrees, 2 cm, CT/ MRVarian Medical Systems Deutschland GmbHJAQ2025-05-16