FDA.reportPublic FDA data

ISORAY MEDICAL, INC

Matched from indexed company URL: ISORAY, INC

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30055200393005520039ISORAY MEDICAL, INC1N2020-04-25350 Hills St Ste 106 RICHLAND WA US 99354

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
M748PL70PL-7 Cs-131 Brachytherapy Seeds in Preloaded Strands with MRI Markers - The Isoray Cesium-131 Implant Devices combined with MRI Markers will be used to facilitate the anatomical location of seeds after they have been implanted in the prostate of a patient with confirmed prostatic malignancy. The PL-7 device is preloaded strands with Markers.509-375-5329customerservice@isoray.com
M748PL80PL-8 Cs-131 Brachytherapy Seeds Preloaded Strands in 18G Needles with MRI Marker - The Isoray Cesium-131 Implant Devices combined with MRI Markers will be used to facilitate the anatomical location of seeds after they have been implanted in the prostate of a patient with confirmed prostatic malignancy. The PL-8 device is preloaded strands with Markers in 18G needles.509-375-5329customerservice@isoray.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
614971281600029K180515GammaTileKXK2018-07-06
614971490232814K132996CESITRX, (LIQUID CESIUM-131 SOLUTION) FOR USE WITH GLIASITE RTSKXK2013-12-17
614971168428179K111931GLIASITE RTSKXK2011-08-05
614972049649441K092458PROXCELAN CS-131PRELOADED STRANDS, MODEL PL-1, PROXCELAN CS-131 PRELOADED STRANDS IN 18 GUAGE NEEDLES, MODEL PL-2KXK2009-08-28
614971980917249K092136PROXCELAN CS-131 PRELOADED BRAIDED STRANDS, MODEL: PL-5KXK2009-08-07
614971688116091K062384CESIUM-131 STRAND, STRAND PRELOAD, PRELOAD, S-CARTRIDGEKXK2006-11-09
614971002895570K030162LAWRENCE CSERION, MODEL CS-1KXK2003-03-28
614971450050094

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
KXK72018-07-06

PMN#

GUDID#