FDA.reportPublic FDA data

NA

Primary DI
08717213036611
Brand
NA
Company
Nucletron B.V.
Model
137064P01-02
Device description
Flexitron Adapter for 5F Catheters
Published
2017-01-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
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
K082530000
K132874000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K070574000FLEXITRONIsodose Control B.V.2007-04-13JAQ
K082530000APPLICATORS FOR AFTERLOADING BRACHYTHERAPYIsodose Control B.V.2008-10-30JAQ
K132874000LUMENCARE AZURE SET F6, 150CM, LUMECARE AZURE SET 5F, 150 CM, LUMENCARE AZURE SET 5F, 140 CMNucletron B.V.2014-02-21JAQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08717213022003Direct MarkingGS10
08717213036611PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08717213022003087172130220038717213022003
08717213036611087172130366118717213036611

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Catheter Gauge5French
Device Size Text, specify0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Humidity20 Percent (%) Relative Humidity75 Percent (%) Relative Humidity
Storage Environment Temperature10 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
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
00841436125451Classic StepperCIVCO MEDICAL INSTRUMENTS CO., INC.JAQ2026-07-23
00816389028081MAASTRO Rectal Applicator Set, ø 26 mmVARIAN MEDICAL SYSTEMS, INC.JAQ2026-06-02
00816389027992Interstitial ovoid pair for 30mm spread, with fixation for guide tubesVARIAN MEDICAL SYSTEMS, INC.JAQ2025-05-21
00816389029460Intrauterine tandem, 15 degrees, 2 cm, CT/ MRVARIAN MEDICAL SYSTEMS, INC.JAQ2025-05-16
00816389029538Intrauterine tandem, 30 degrees, 8 cm, CT/ MRVARIAN MEDICAL SYSTEMS, INC.JAQ2025-05-16
00816389029637Ovoid, 40 mm, pair, CT/ MRVARIAN MEDICAL SYSTEMS, INC.JAQ2025-05-16
00816389029699Assembly module, CT/ MRVARIAN MEDICAL SYSTEMS, INC.JAQ2025-05-16
00816389029712Retractor, 30 mm, CT/ MRVARIAN MEDICAL SYSTEMS, INC.JAQ2025-05-16
00816389029743Retraction Nut CT/MRVARIAN MEDICAL SYSTEMS, INC.JAQ2025-05-16
00810563022551Needle collector pair for Titanium Fletcher-style applicatorVARIAN MEDICAL SYSTEMS, INC.JAQ2024-11-19
00816389020245Crook Prostate Template for 2.0 mm needlesVARIAN MEDICAL SYSTEMS, INC.JAQ2024-02-19
00816389020276Crook Prostate Template for 17 gauge (1.47 mm) needlesVARIAN MEDICAL SYSTEMS, INC.JAQ2024-02-19
00810563022025Plastic needle MR safe, 2.0 mm diameter x 113 mm length, with mandrinVARIAN MEDICAL SYSTEMS, INC.JAQ2024-02-16
00816389029286Stainless steel needle 320mm, 18 gauge, trocar pointVARIAN MEDICAL SYSTEMS, INC.JAQ2023-05-05
00816389029217Stainless steel needle 113mm, 17 gauge, trocar pointVARIAN MEDICAL SYSTEMS, INC.JAQ2023-04-28
00816389029224Stainless steel needle 200mm, 17 gauge, trocar pointVARIAN MEDICAL SYSTEMS, INC.JAQ2023-04-28
00816389029255Stainless steel needle 113mm, 18 gauge, trocar pointVARIAN MEDICAL SYSTEMS, INC.JAQ2023-04-28
00816389028869VariSource VS2000 HDR Ir 192 Brachytherapy Sealed SourceVARIAN MEDICAL SYSTEMS, INC.JAQ2022-01-09
00816389027756Varian Titanium Applicator probe, 3mm dia x 320mm length, curved 15 degree, 50mmVARIAN MEDICAL SYSTEMS, INC.JAQ2019-11-06
08717213008472Shielded Cylindrical ApplicatorNucletron B.V.JAQ2018-07-11
08717213008892NANucletron B.V.JAQ2018-07-11
08717213008908NANucletron B.V.JAQ2018-07-11
08717213008915NANucletron B.V.JAQ2018-07-11
08717213009578Miami Vaginal ApplicatorNucletron B.V.JAQ2018-07-11
08717213007772Fletcher Williamson ApplicatorNucletron B.V.JAQ2018-07-06
08717213007796Fletcher Williamson ApplicatorNucletron B.V.JAQ2018-07-06
08717213007826Fletcher Williamson ApplicatorNucletron B.V.JAQ2018-07-06
08717213009318Esophageal ApplicatorNucletron B.V.JAQ2018-06-27
08717213007765Esophageal ApplicatorNucletron B.V.JAQ2018-06-20
08717213009042Esophageal ApplicatorNucletron B.V.JAQ2018-06-20