FDA.reportPublic FDA data

Advantage I-125

Primary DI
M936IRLS15SSS9
Brand
Advantage I-125
Company
ISOAID, L.L.C.
Model
RSLN-15SSS
Device description
Radioactive seed localization, seed and spacer, stranded
Published
2025-03-04
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Sterile
true
Single use
true

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
K141701000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K141701000I-125 RSLN [RADIOACTIVE SEED AND LOCALIZATION NEEDLE]Isoaid, LLC2014-12-05KXK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M936IRLS15SSS9PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Manual brachytherapy source, temporary placementA device that is a naturally-occurring, accelerator- or reactor-produced radioactive isotope in a form that is intended for temporary placement in the body and removal after a specified treatment time. It is used in brachytherapy applications that require direct manual or endoscopically-guided placement and removal. Manually inserted sources intended for temporary placement come in a variety of forms, e.g., encapsulated, sealed, plated, foil or embedded sources. It can be inserted directly into the patient or be implanted using catheters or applicators and may take the form of needles, spheres, ovoids, seeds, wires or liquids included in the cuffed portion of a catheter.

Regulatory Flags#

DUNS number
002751241
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
M936IIS4721IsoSphereIIS4722026-05-12
M936PDIS4721IsoSpherePdIS4722026-05-12
M936IRLS15S9Advantage I-125RSLN-15S2025-03-04
M936IRLS15SS9Advantage I-125RSLN-15SS2025-03-04
M936IBKAL9Advantage-Load® with Advantage I-125®IBKA2016-02-04
M936IBKAS9Advantage-Strand® with Advantage I-125®IBKA2016-02-04
M936IBKASAL9Advantage-Strand® and Advantage-Load® with Advantage I-125® IBKA2016-02-04
M936IBKSS9Secure Strand® with Advantage I-125®IBKS2016-02-04
M936IBKSSAL9Advantage I-125®IBKS2016-02-04
M936PBKAL9Advantage-Load® with Advantage Pd-103® PBKA2016-02-04
M936PBKAS9Advantage-Strand® with Advantage Pd-103® PBKA2016-02-04
M936PBKASAL9Advantage-Strand® and Advantage-Load® and Advantage Pd-103® PBKA2016-02-04
M936PBKSS9Secure Strand® with Advantage Pd-103®PBKS2016-02-04
M936PBKSSAL9Secure Strand® and Advantage-Load® with Advantage Pd-103®PBKS2016-02-04
M936BGNS0Guide NeedleBGNS2016-02-04
M936IRLS20S9Advantage I-125®RSLN-202022-02-07
M936IRLS20SS9Advantage I-125®RSLN-20RSLN2022-02-07
M936IRLS20SSS9Advantage I-125®RSLN-20RSLN2022-02-07
M936IRLS20S0Advantage I-125®RSLN-20RSLN2022-02-07
M936IRLS20SS0Advantage I-125®RSLN-20RSLN2022-02-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
M936IIS4721IsoSphereISOAID, L.L.C.KXK2026-05-12
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
M936IRLS20SSS9Advantage 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