FDA.reportPublic FDA data

selectSeed™ I-125

Primary DI
98717213037833
Brand
selectSeed™ I-125
Company
Nucletron B.V.
Model
130002-01
Catalog number
130002
Device description
Sterile IODINE—125 source for interstitial Brachytherapy for use with seedSelectron®. Quantity in package is customer order specific in range 10 – 100 seeds.
Published
2015-10-22
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KXKSource, Brachytherapy, Radionuclide

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KXKSource, Brachytherapy, RadionuclideRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K002429000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K002429000SELECT SEED I-125Nucletron Corp.2001-02-02KXK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
98717213037833PrimaryGS10
08717213038066Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
9871721303783398717213037833
08717213038066087172130380668717213038066

GMDN Terms#

Term, Definition table
TermDefinition
Remote-afterloading brachytherapy sourceA device that is a naturally-occurring, accelerator or reactor produced-radioactive isotope used as a source of radiation in high or low dose rate remote afterloading brachytherapy systems designed to deliver curative or palliative radiotherapy treatments. Sources used in remote afterloading radiotherapy systems may come in a variety of strengths and physical forms, e.g., single encapsulated source (sealed source), ribbons, plated, foil or embedded sources or contained radioactive liquids or gels. It is typically housed in a shielded safe within the remote afterloading system and delivered through guide tubes or catheters to the treatment site by various remote-controlled mechanisms.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Storage of selectSeeds™ I-125 has to be in a place with adequate radiation protection that is safe from unauthorized access, in accordance with the regulations of radionuclide laboratories.
Storage Environment Temperature-40 Degrees Celsius70 Degrees Celsius
Storage Environment Temperature-40 Degrees Fahrenheit158 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
770 300 9725info.america@elekta.com

Regulatory Flags#

DUNS number
415269930
Device count
100
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
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
M936IIS4721IsoSphereISOAID, L.L.C.KXK2026-05-12
M936IRLS15SSS9Advantage I-125ISOAID, L.L.C.KXK2025-03-04
00850645007007AOS Marker SeedsALPHA-OMEGA SERVICES, INC.KXK2024-07-15
B887MRTLS050515200VISICOIL MR Twin LineIzi Medical Products, LLCKXK2022-06-03
B887MRTLS075515180VISICOIL MR Twin LineIzi Medical Products, LLCKXK2022-06-03
M936IRLS20S9Advantage I-125®ISOAID, L.L.C.KXK2022-02-07
M936IRLS20SS9Advantage I-125®ISOAID, L.L.C.KXK2022-02-07
008152120213362PK 0.8X3.0MM GOLD FIDUCIAL LOOSEIzi Medical Products, LLCKXK2021-10-15
10801741184120SourceLink™Bard Brachytherapy, Inc.KXK2020-08-06
10801741184137SourceLink™Bard Brachytherapy, Inc.KXK2020-08-06
00813787021799TheragenicsTHERAGENICS CORPORATIONKXK2020-07-15
00813787021805TheragenicsTHERAGENICS CORPORATIONKXK2020-07-15
00813787021812TheragenicsTHERAGENICS CORPORATIONKXK2020-07-15
00813787021829TheragenicsTHERAGENICS CORPORATIONKXK2020-07-15
00813787021843TheragenicsTHERAGENICS CORPORATIONKXK2020-07-15
00813787021850TheragenicsTHERAGENICS CORPORATIONKXK2020-07-15
00813787021867TheragenicsTHERAGENICS CORPORATIONKXK2020-07-15
00813787021836TheragenicsTHERAGENICS CORPORATIONKXK2020-07-08
00853162006430Stellar MedicalSTELLAR MEDICAL, LLCKXK2020-05-28
00853162006447Stellar MedicalSTELLAR MEDICAL, LLCKXK2020-05-28
00853162006577Stellar MedicalSTELLAR MEDICAL, LLCKXK2020-05-28
00853162006607Stellar MedicalSTELLAR MEDICAL, LLCKXK2020-05-28
B887MRTL050415200VISICOIL MR Twin LineIzi Medical Products, LLCKXK2020-04-30
B887MRTL050415210VISICOIL MR Twin LineIzi Medical Products, LLCKXK2020-04-30
B887MRTL050820210VISICOIL MR Twin LineIzi Medical Products, LLCKXK2020-04-30
B887MRTL075415190VISICOIL MR Twin LineIzi Medical Products, LLCKXK2020-04-30
B887MRTL075820190VISICOIL MR Twin LineIzi Medical Products, LLCKXK2020-04-30
B887MRTLS075920180VISICOIL MR Twin LineIzi Medical Products, LLCKXK2020-04-30
B887PTTL050110210VISICOIL MR Twin LineIzi Medical Products, LLCKXK2020-04-30
B887TL050215200VISICOILIzi Medical Products, LLCKXK2020-04-30