FDA.reportPublic FDA data

I-125 SeedsTM in Carrier

Primary DI
00840682100540
Brand
I-125 SeedsTM in Carrier
Company
MEDI-PHYSICS, INC.
Model
6720 - I-125 Seeds 0.863 mCi
Catalog number
6720-00863
Published
2015-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
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
00840682100540PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840682100540008406821005408406821005400840682100540

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

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

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
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
00840682100618I-125 SeedsTM in Carrier6720 - I-125 Seeds 0.733 mCi6720-007332015-09-24

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