FDA.reportPublic FDA data

Advantage Pd-103®

Primary DI
M936PEPS9
Brand
Advantage Pd-103®
Company
ISOAID, L.L.C.
Model
PEPS
Device description
Advantage Pd-103 radioactive seeds with a molded form that is shielded on one side containing grooved positions for manual brachytherapy sources on the other side used for the temporary topical application of brachytherapy sources to the surface of the eye; sterile.
Published
2016-02-04
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M936PEPS9PrimaryHIBCC0
M936PEPSUnit of UseHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Eye brachytherapy system applicator, manualA device in the form of a template that is shielded on one side and containing grooved positions for manual brachytherapy sources on the other used for the temporary topical application of brachytherapy sources to the surface of the eye.

Sterilization Methods#

Method table
Method
"[""Ethylene Oxide"", ""Moist Heat or Steam Sterilization""]"

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
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