FDA.reportPublic FDA data

NA

Primary DI
08717213007727
Brand
NA
Company
Nucletron B.V.
Model
084008-02
Device description
Perineal Bar and Lockingscrew
Published
2019-09-18
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe

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
08717213007727PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08717213007727087172130077278717213007727

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 Humidity0 Percent (%) Relative Humidity90 Percent (%) Relative Humidity

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
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08717213060746Rectal Applicator153106-012026-04-20
08717213060937Fixation Element153202-012026-04-20
08717213060951Fixation Clip153203-012026-04-20
08717213060975Insertion Tool153204-012026-04-20
08717213055919Geneva152001-002020-08-12
08717213055933Geneva152002-002020-08-15
08717213055957Geneva152003-002020-08-13
08717213055971Geneva152004-002020-08-13
08717213055995Geneva152005-002020-08-13
08717213056015Geneva152006-002020-08-15
08717213056039Geneva152007-002020-08-14
08717213056053Geneva152008-002020-08-15
08717213056077Geneva152009-002020-08-14
08717213056091Geneva152010-002020-08-14
08717213056299Geneva152037-002020-08-14
08717213056312Geneva152038-002020-08-14
08717213056336Geneva152039-002020-08-14
08717213056398Geneva152011-002020-08-13
08717213056411Geneva152012-002020-08-15
08717213056435Geneva152013-002020-08-14

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