FDA.reportPublic FDA data

I-Seed Agx100

Primary DI
00813787020259
Brand
I-Seed Agx100
Company
THERAGENICS CORPORATION
Model
XX5056iN
Device description
IsoLoader magazines in TPSII Ind. - 20 seeds per mag- STERILE
Published
2015-09-21
Public version status
Update
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
K103319000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K103319000I-SEEDTheragenics Corp.2011-01-03KXK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00813787020259PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00813787020259008137870202598137870202590813787020259

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
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
114379522
Device count
1
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
00813787021737TheragenicsCPPS-MN-1821-12022-04-26
00813787021744TheragenicsCPPS-MN-1821-252022-04-26
00813787021751TheragenicsCPPS-MN-1821-52022-04-26
00813787021911TheragenicsCPPS-1820X-202021-04-28
00813787022031TheragenicsCPPS-SQ-1820X-NS2021-04-12
00813787022048TheragenicsCPPS-BT-1820X-NS2021-04-12
00813787021980TheragenicsCPPS-SQ-1830X-12020-09-22
00813787020983TheragenicsTG31212015-09-28
00813787020990TheragenicsTG31222015-09-28
00813787021003TheragenicsTG31232015-09-28
00813787021010TheragenicsTG31242015-09-28
00813787021027TheragenicsTG31252015-09-28
00813787021034TheragenicsTG31262015-09-28
00813787021041TheragenicsTG34272015-09-28
00813787021058TheragenicsTG34282015-09-28
00813787021065TheragenicsTG34292015-09-28
00813787021072TheragenicsTG34302015-09-28
00813787021089TheragenicsTG34312015-09-28
00813787021096TheragenicsTG34322015-09-28
00813787021195AnchorMarkerAM0845SL3-12016-02-02

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