FDA.reportPublic FDA data

Advantage I-125®

Primary DI
M936ILVS9
Brand
Advantage I-125®
Company
ISOAID, L.L.C.
Model
ILVS
Device description
Radioactive I-125 seeds, loose, in vial
Published
2016-02-04
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Safe
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
K011205000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K011205000ISOAID IODINE BRACHTHERAPY SEEDS, MODEL ADVANTAGE I-125Isoaid2001-07-10KXK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M936ILVS9PrimaryHIBCC0
M936ILVSUnit of UseHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Manual brachytherapy source, permanent implantA device that is a naturally-occurring, accelerator- or reactor-produced radioactive isotope and intended to be permanently implanted into the body in order to deliver curative or palliative radiotherapy treatments. It is typically placed in the body by means of an applicator using either fluoroscopic or endoscopic guidance. Manually implanted sources intended for permanent implantation are designed to be histocompatible. It may take the form of, e.g., microspheres, spheres, stents, seeds or wires selected for producing low energy photons, beta or alpha particles.

Sterilization Methods#

Method table
Method
Ethylene Oxide

Regulatory Flags#

DUNS number
002751241
Device count
9
DM exempt
true
Lot or batch
true
Expiration date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
M936IIS4721IsoSphereIIS4722026-05-12
M936PDIS4721IsoSpherePdIS4722026-05-12
M936IRLS15SSS9Advantage I-125RSLN-15SSS2025-03-04
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
M936IIS4721IsoSphereISOAID, L.L.C.KXK2026-05-12
M936PDIS4721IsoSphereISOAID, L.L.C.KXK2026-05-12
00841365121531Best Medical InternationalBEST MEDICAL INTERNATIONAL, INC.KXK2026-05-04
00841365121500Best Medical InternationalBEST MEDICAL INTERNATIONAL, INC.KXK2026-04-03
00841365121425Best Medical InternationalBEST MEDICAL INTERNATIONAL, INC.KXK2025-12-16
00841365121388Best Medical InternationalBEST MEDICAL INTERNATIONAL, INC.KXK2025-10-20
M936IRLS15SSS9Advantage I-125ISOAID, L.L.C.KXK2025-03-04
M936IRLS15S9Advantage I-125ISOAID, L.L.C.KXK2025-03-04
M936IRLS15SS9Advantage I-125ISOAID, L.L.C.KXK2025-03-04
00850645007007AOS Marker SeedsALPHA-OMEGA SERVICES, INC.KXK2024-07-15
00860000064545GammaTileGT MEDICAL TECHNOLOGIES, INC.KXK2024-04-29
20860000064549GammaTileGT MEDICAL TECHNOLOGIES, INC.KXK2024-04-29
00860000064569CS-1GT MEDICAL TECHNOLOGIES, INC.KXK2024-04-29
00860000064576CS-1GT MEDICAL TECHNOLOGIES, INC.KXK2024-04-29
00860000064583PL-1GT MEDICAL TECHNOLOGIES, INC.KXK2024-04-29
00860000064590PL-5GT MEDICAL TECHNOLOGIES, INC.KXK2024-04-29
00860011485407PL-2GT MEDICAL TECHNOLOGIES, INC.KXK2024-04-29
00860011485414PL-3GT MEDICAL TECHNOLOGIES, INC.KXK2024-04-29
00860011485421PL-4GT MEDICAL TECHNOLOGIES, INC.KXK2024-04-29
00860011485438PL-4NSGT MEDICAL TECHNOLOGIES, INC.KXK2024-04-29
00860011485445PL-5MGT MEDICAL TECHNOLOGIES, INC.KXK2024-04-29
00860011485452PL-7GT MEDICAL TECHNOLOGIES, INC.KXK2024-04-29
00860011485469PL-8GT MEDICAL TECHNOLOGIES, INC.KXK2024-04-29
00841365120688Best Medical InternationalBEST MEDICAL INTERNATIONAL, INC.KXK2024-03-14
00841365120640Best Medical InternationalBEST MEDICAL INTERNATIONAL, INC.KXK2024-01-29
00850800006067VariSeedVARIAN MEDICAL SYSTEMS, INC.KXK2023-09-15
00841365120503Best Medical InternationalBEST MEDICAL INTERNATIONAL, INC.KXK2023-08-21
00841365120510Best Medical InternationalBEST MEDICAL INTERNATIONAL, INC.KXK2023-08-21
00841365120213Best Medical InternationalBEST MEDICAL INTERNATIONAL, INC.KXK2023-03-29
B887MRTLS050515200VISICOIL MR Twin LineIzi Medical Products, LLCKXK2022-06-03