FDA.reportPublic FDA data

I-Seed Agx100

Primary DI
00813787020280
Brand
I-Seed Agx100
Company
THERAGENICS CORPORATION
Model
XX1525i
Device description
Seeds for IsoCartridge - 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
KPTCalibrator, Dose, Radionuclide

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KPTCalibrator, Dose, RadionuclideRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K011493000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K011493000MENTOR ISOLOADER AUTOMATIC NEEDLE LOADING SYSTEM AND PHYSICS WORKSTATION FOR BRACHYTHERAPYMentor Corp.2002-10-01KPT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00813787020280PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00813787020280008137870202808137870202800813787020280

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
Ethylene Oxide

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
00718175003343Atomlab Wipe Test CounterBIODEX MEDICAL SYSTEMS, INC.KPT2020-02-14
08719324589017VIK203Comecer Netherlands B.V.KPT2018-02-06
08719324589024IBC-LiteComecer Netherlands B.V.KPT2018-02-06
08719324589048VDC606Comecer Netherlands B.V.KPT2018-02-06
08719324589000VIK202Comecer Netherlands B.V.KPT2018-02-05
00859942006065Capintec Dose CalibratorMirion Technologies (capintec), Inc.KPT2017-06-20
00718175003305Atomlab 500 Dose CalibratorBIODEX MEDICAL SYSTEMS, INC.KPT2016-11-02
00718175003329Atomlab 500 PlusBIODEX MEDICAL SYSTEMS, INC.KPT2016-11-02
00718175003350Atomlab Dose CalibratorBIODEX MEDICAL SYSTEMS, INC.KPT2016-11-02
00866562000212Standard Imaging HDR 1000 PlusSTANDARD IMAGING INC.KPT2016-10-11
00866562000250Standard Imaging IVB 1000 Well ChamberSTANDARD IMAGING INC.KPT2016-10-11
00859942006072Capintec Dose CalibratorMirion Technologies (capintec), Inc.KPT2016-09-27
00859942006089Capintec Dose CalibratorMirion Technologies (capintec), Inc.KPT2016-09-27
00859942006003Capintec Dose CalibratorMirion Technologies (capintec), Inc.KPT2016-09-14
00859942006010Capintec Dose CalibratorMirion Technologies (capintec), Inc.KPT2016-09-14
00859942006027Capintec Dose CalibratorMirion Technologies (capintec), Inc.KPT2016-09-14
00859942006034Capintec Dose CalibratorMirion Technologies (capintec), Inc.KPT2016-09-14
00859942006041Capintec Dose CalibratorMirion Technologies (capintec), Inc.KPT2016-09-14
00859942006058Capintec Dose CalibratorMirion Technologies (capintec), Inc.KPT2016-09-14
00813787020297I-Seed Agx100THERAGENICS CORPORATIONKPT2015-09-21
00813787020754TheraSeedTHERAGENICS CORPORATIONKPT2015-09-21
00813787020761TheraSeedTHERAGENICS CORPORATIONKPT2015-09-21