FDA.reportPublic FDA data

MicroSelectron Digital

Primary DI
08717213041479
Brand
MicroSelectron Digital
Company
Nucletron B.V.
Model
106210P01-01
Device description
Patient Belt Coupling Bracket
Published
2016-12-01
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
K061354000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K061354000MICROSELECTRON V3, MODEL 106.990Nucletron Corporation2006-08-17JAQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08717213041479PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08717213041479087172130414798717213041479

GMDN Terms#

Term, Definition table
TermDefinition
Brachytherapy system remote afterloading source transfer tubeA tube or hose-like catheter with connectors at both ends used to interface the brachytherapy applicator to the remote afterloading system. The transfer tube, when attached to the applicator and the afterloading system, provides a continuous closed passage that allows for moving either a radioactive source(s) and/or positioning markers from the shielded source storage compartment of the remote afterloading brachytherapy system into appropriate positions within a brachytherapy applicator that has been positioned at a location either on the surface of, or within, the patient.

Contacts#

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

Regulatory Flags#

DUNS number
415269930
Device count
1
DM exempt
true
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