FDA.reportPublic FDA data

THERAGENICS CORP.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
10375981037598THERAGENICS CORP.1N2026-01-015203 BRISTOL INDUSTRIAL WAY BUFORD GA US 30518
30116231453011623145Theragenics Costa Rica Limitada1N2026-01-01Zona Franca El Coyol, Building B 13.3 El Coyol Alajuela CR 20113

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
4292061752021K974118WORLDWIDE MEDICAL TECHNOLOGIES SEED IMPLANT NEEDLE SETIWJ1998-01-23
1971431678251487K192195Sterile DilatorDRE2019-09-26
1971431665475832K172487Coaxial Dilator Set (Micro-Introducer)DRE2017-10-16
1971431127760062K123430MICROSLIDER TEARAWAY INTRODUCER SETDYB2013-04-12
4291742953846K111979RADIOACTIVE SEED LOCALIZATION NEEDLEKXK2011-10-18
4291740817715K103319I-SEEDKXK2011-01-03
4291075991080K083274WORLDWIDE MEDICAL TECHNOLOGIES ANCHOR MARKER, MARKER STRAND AND MARKERKXK2009-01-08
4291910411391K072296POIINT OF CARE STRANDING SYSTEM, MODE 1004-00KXK2007-09-26
4291941638970K071550PRE-WAXED NEEDLES WITH GOLD FIDUCIARY MARKERSKXK2007-07-18
1971431700306330K071330GALTSTICK INTRODUCER SYSTEMDRE2007-10-31
4292048734023K060987OSCERA7 SYNTHETIC ABSORBABLE BONE WAX, MODEL OS31MTJ2006-11-02
4291356169062K043596THERALOAD CUSTOM LOADED NEEDLES, MODELS 200 AND 125.S06KXK2005-01-26
1971431465743914K043525CATHETER INTRODUCERDYB2005-02-09
4291067483360K040339BRACHYTHERAPY STRAND DEVICEKXK2004-04-08
4291891315088K034062CP SLEEVE AND RIVER SLEEVEKXK2004-01-30
4291914874985K023179READI-STRAND, MODEL PSSTRANDKXK2003-07-02
4291684529436K021343ISOSEEDS I-125KXK2002-05-20
4291980153791K021311SYNTHETIC ABSORBABLE SEEDING SPACERS MADE OF POLYDIOXANONE MATERIALKXK2002-07-13
4291948276853K013975CP-SLEEVEKXK2002-02-22
4291456586898K013964MODIFICATION TO ACCU-SPACE PLAIN GUT ABSORBABLE SEEDING SPACERSKXK2002-01-24
4291972275226K011493MENTOR ISOLOADER AUTOMATIC NEEDLE LOADING SYSTEM AND PHYSICS WORKSTATION FOR BRACHYTHERAPYKPT2002-10-01
4291628942864K010621ACCU-SPACE ABSORBABLE SEEDING SPACERSKXK2001-09-04
4291223928454K010283THERASEED(R) PALLADIUM-103 IMPLANT; MODEL 200KXK2001-04-26
1971431855815254K000737COAXIAL DILATOR SETDRE2000-08-01
1971431108758527K000313TEARAWAY INTRODUCER SHEATHDYB2000-06-16
1971431067056713
4292069650198

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
KXK232011-10-18
DRE42019-09-26
DYB32013-04-12
IWJ21998-01-23
MTJ12006-11-02
KPT12002-10-01

PMN#

I-SEED

2011-01-03

THERAGENICS CORP.

GUDID#

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