FDA.reportPublic FDA data

NA

Primary DI
08717213039155
Brand
NA
Company
Nucletron B.V.
Model
137043-00
Device description
SPCR Adapter Set 6F Cath.
Published
2016-10-27
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

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
K070574000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K070574000FLEXITRONIsodose Control B.V.2007-04-13JAQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08717213038912Direct MarkingGS10
08717213039155PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08717213038912087172130389128717213038912
08717213039155087172130391558717213039155

GMDN Terms#

Term, Definition table
TermDefinition
Remote-afterloading brachytherapy systemAn assembly of devices using a remotely-controlled radioactive source transport system designed to deliver a therapeutic or palliative radiation dose from a single source or source train to an anatomical region by placing the radioactive source(s) temporarily on or in the treatment site. A standard system consists of 1) a single radioactive source or source train in various forms; 2) a shielded vault to hold the sources when not used; 3) guide tubes/catheters to remotely direct the sources to the treatment site; 4) a remote-controlled mechanism to move the sources inside the guide tubes/catheters; 5) applicators; 6) computer treatment planning programs; and 7) an operator's console.

Contacts#

Phone, Email table
PhoneEmail
+1(770)300-9725info.america@elekta.com

Regulatory Flags#

DUNS number
415269930
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08717213041288X-ray Catheters101066P01-012016-09-10
08717213041295X-ray Catheters101067P01-012016-09-10
08717213041301X-ray Catheters101068P01-012016-09-10
08717213041318X-ray Catheters101069P01-012016-09-10
08717213041721NA089401P01-012016-09-10
08717213042513X-ray Catheters084881P01-002016-09-10
08717213042520X-ray Catheters084882P01-002016-09-10
08717213042537X-ray Catheters085076P01-002016-09-10
08717213042544X-ray Catheters085077P01-002016-09-10
08717213042551X-ray Catheters085078P01-002016-09-10
08717213042568X-ray Catheters085079P01-002016-09-10
08717213042605X-ray Catheters089423P01-002016-09-10
08717213042612X-ray Catheters089424P01-002016-09-10
08717213042629X-ray Catheters089425P01-002016-09-10
08717213042636X-ray Catheters089426P01-002016-09-10
08717213042643X-ray Catheters089427P01-002016-09-10
08717213042650X-ray Catheters089428P01-002016-09-10
08717213042667X-ray Catheters089429P01-002016-09-10
08717213042674X-ray Catheters089430P01-002016-09-10
08717213042681X-ray Catheters089431P01-002016-09-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00841436125451Classic StepperCIVCO MEDICAL INSTRUMENTS CO., INC.JAQ2026-07-23
00810563022551Needle collector pair for Titanium Fletcher-style applicatorVARIAN MEDICAL SYSTEMS, INC.JAQ2024-11-19
00850645007007AOS Marker SeedsALPHA-OMEGA SERVICES, INC.JAQ2024-07-15
00816389020245Crook Prostate Template for 2.0 mm needlesVARIAN MEDICAL SYSTEMS, INC.JAQ2024-02-19
00810563021967Plastic needle MR safe, 2.0 mm diameter x 200 mm length, with mandrinVARIAN MEDICAL SYSTEMS, INC.JAQ2024-02-16
00810563021974Plastic needle MR safe, 2.0 mm diameter x 320 mm length, with mandrinVARIAN MEDICAL SYSTEMS, INC.JAQ2024-02-16
00810563021981Plastic needle MR safe, 2.0 mm diameter x 320 mm length, blunt tip, with mandrinVARIAN MEDICAL SYSTEMS, INC.JAQ2024-02-16
00810563022001Mandrin for 200 mm lengthVARIAN MEDICAL SYSTEMS, INC.JAQ2024-02-16
00810563022018Mandrin for 320 mm lengthVARIAN MEDICAL SYSTEMS, INC.JAQ2024-02-16
00810563022025Plastic needle MR safe, 2.0 mm diameter x 113 mm length, with mandrinVARIAN MEDICAL SYSTEMS, INC.JAQ2024-02-16
00810563021998Mandrin for 113 mm lengthVARIAN MEDICAL SYSTEMS, INC.JAQ2024-02-16
00816389022522Mandrin for 200mm length Needle for Plastic Interstitial NeedleVARIAN MEDICAL SYSTEMS, INC.JAQ2021-02-02
00863593000235HDR MRI Lumen MarkerC4 IMAGING, LLCJAQ2018-06-11
08717213043329X-ray CathetersNucletron B.V.JAQ2016-09-25
08717213043336X-ray CathetersNucletron B.V.JAQ2016-09-25
08717213043343X-ray CathetersNucletron B.V.JAQ2016-09-25
08717213043688X-ray CathetersNucletron B.V.JAQ2016-09-25
08717213043695X-ray CathetersNucletron B.V.JAQ2016-09-25
08717213043701X-ray CathetersNucletron B.V.JAQ2016-09-25
08717213043718X-ray CathetersNucletron B.V.JAQ2016-09-25
08717213043725X-ray CathetersNucletron B.V.JAQ2016-09-25
08717213043732X-ray CathetersNucletron B.V.JAQ2016-09-25
08717213043749X-ray CathetersNucletron B.V.JAQ2016-09-25
08717213043756X-ray CathetersNucletron B.V.JAQ2016-09-25
08717213043763X-ray CathetersNucletron B.V.JAQ2016-09-25
08717213021662X-ray CathetersNucletron B.V.JAQ2016-09-25
08717213028463X-ray CathetersNucletron B.V.JAQ2016-09-25
10816389027296Universal fixation button, radiopaque, pack of 100, non-sterileVARIAN MEDICAL SYSTEMS, INC.JAQ2016-09-23
00816389021747Central clamping mechanismVARIAN MEDICAL SYSTEMS, INC.JAQ2016-09-23
00816389021778Intrauterine probe with stop, 30 degrees angle, length 80mmVARIAN MEDICAL SYSTEMS, INC.JAQ2016-09-23