FDA.reportPublic FDA data

OncoSeedTM

Primary DI
00840682101981
Brand
OncoSeedTM
Company
MEDI-PHYSICS, INC.
Model
6711 - Iodine I-125 Seed 0.199 mCi
Catalog number
6711-00199
Published
2015-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840682101981PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840682101981008406821019818406821019810840682101981

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"", ""Ethylene Oxide""]"
Moist Heat or Steam Sterilization;Ethylene Oxide

Contacts#

Phone, Email table
PhoneEmail
+1(800)228-0126xx@xx.xx

Regulatory Flags#

DUNS number
059470927
Device count
1
Serial number
true
Expiration date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840682100403OncoSeedTM6711 - Iodine I-125 Seed 0.574 mCi6711-005742015-09-24
00840682100427I-125 SeedTM Sterile Convenience Pack6715 - I-125 Seed 0.449mCi6715-004492015-09-24
00840682100434I-125 SeedTM Sterile Convenience Pack6715 - I-125 Seed 0.414mCi6715-004142015-09-24
00840682100441OncoSeedTM6711 - Iodine I-125 Seed 0.234 mCi6711-002342015-09-24
00840682100458RAPID StrandTM Rx 6717 RSRx Loose Square Needle6717 I125NVG2015-09-24
00840682100465Thin SeedTM9011 - I-125 Seed 0.937 mCi9011-009372015-09-24
00840682100472OncoSeedTM6711 - Iodine I-125 Seed 19.21 mCi6711-192102015-09-24
00840682100489OncoSeedTM6711 - Iodine I-125 Seed 55.5 mCi6711-555002015-09-24
00840682100496RAPID STRANDTM7000 - I-125 Seed 0.352 mCi7000-003522015-09-24
00840682100502OncoSeedTM6711 - Iodine I-125 Seed 5.64 mCi6711-056402015-09-24
00840682100519RAPID StrandTM Rx MICK671010 Disposable Cartridge671010-I125DCAAS2015-09-24
00840682100526OncoSeedTM6711 - Iodine I-125 Seed 0.254 mCi6711-002542015-09-24
00840682100533RAPID STRANDTM7000 - I-125 Seed 1.016 mCi7000-010162015-09-24
00840682100540I-125 SeedsTM in Carrier6720 - I-125 Seeds 0.863 mCi6720-008632015-09-24
00840682100557I-125 SeedsTM in Carrier6720- I-125 Seeds 0.937 mCi6720-009372015-09-24
00840682100564Thin SeedTM9011 - I-125 Seed 0.254 mCi9011-002542015-09-24
00840682100571RAPID STRANDTM7000 - I-125 Seed 0.324 mCi7000-003242015-09-24
00840682100588Thin SeedTM9011 - I-125 Seed 0.299 mCi9011-002992015-09-24
00840682100595Thin SeedTM9011 - I-125 Seed 0.529 mCi9011-005292015-09-24
00840682100601I-125 SeedsTM in Carrier6720 - I-125 Seeds 0.215 mCi6720-002152015-09-24

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