FDA.report

Thin SeedTM Iodine-125

Primary DI
00840682102391
Brand
Thin SeedTM Iodine-125
Company
MEDI-PHYSICS, INC.
Model
9011 TSRx Loose Round Needle
Catalog number
9019-I125NVG
Published
2015-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
KXKSource, brachytherapy, radionuclide

Product Code Classifications

CodeDeviceSpecialtyClass
KXKSource, Brachytherapy, RadionuclideRadiology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00840682102391PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00840682102391008406821023918406821023910840682102391

GMDN Terms

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

Contacts

PhoneEmail
+1(800)228-0126xx@xx.xx

Regulatory Flags

DUNS number
059470927
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

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 DIBrandCompanyProduct codePublished
00841365121425Best Medical InternationalBEST MEDICAL INTERNATIONAL, INC.KXK2025-12-16
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
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
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
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00813787022284TheraMark™THERAGENICS CORPORATIONKXK2022-05-25
00813787022291TheraMark™THERAGENICS CORPORATIONKXK2022-05-25
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