Irradiator, Blood To Prevent Graft Versus Host Disease

Product Code: MOT

Radioisotope Therapy Devices

Definition: Radiation Emitting Electronic Product Codes // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration   Follow FDA En Español Search FDA   Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Co

Applicable Standards: No Standard Applicable. General Radiological Health Requirements Apply. [1000-1005]

Code of Federal Regulations:


Radiation TypeIonizing
Radition SafetyNone
Annual ReportsNo

Products Classified as MOT

5439Irradiator, Blood To Prevent Graft Versus Host Disease

Total Product Life Cycle (TPLC) Devices

5439Irradiator, Blood To Prevent Graft Versus Host Disease

Pre-market Notifications for MOT

K201177RadGil2R3 X-Ray L.L.C
K181737Raycell MK1Best Theratronics Limited
K172087SANGRAYHitachi Ltd.
K161324Raycell Mk2Best Theratronics Limited
K082921RAD SOURCE X-RAY BLOOD IRRADIATOR, MODEL RS-3400RAD SOURCE TECHNOLOGIES, INC.
K051065RAYCELL X-RAY BLOOD IRRADIATORMDS NORDION
K050963GAMMACELL 1000 ELITE AND GAMMACELL 3000 ELANMDS NORDION
K032684RAYCELLMDS NORDION
K974210SHIELDED CABINET X-RAY RADIATION SOURCE DEVICE MODEL RS 3000RAD-SOURCE, INC.
K963497GAMMACELL 3000 ELAN, VERSION 1.0 AND GAMMACELL 1000 ELITE, VERSION 1.0NORDION INTERNATIONAL, INC.
K952291GAMMACELL 3000 ELANNORDION INTERNATIONAL, INC.
K915766MODEL 109 SERIES BLOOD PRODUCTS IRRADIATORSJ. L. SHEPHERD AND ASSOC.
K915767MODEL 143 SERIES BLOOD PRODUCT IRRADIATORSJ. L. SHEPHERD AND ASSOC.
K851828IRRADIATOR FOR BIOLOGICAL MATERIALS IBL-437-CSYNCOR INTL. CORP.

Global Unique Device Identification Database

00754014600045Irradiator, Blood To Prevent Graft Versus Host Disease
00754014600021Irradiator, Blood To Prevent Graft Versus Host Disease
00754014600014Irradiator, Blood To Prevent Graft Versus Host Disease
00860000737005Irradiator, Blood To Prevent Graft Versus Host Disease
00754014600106Irradiator, Blood To Prevent Graft Versus Host Disease
07540146000104Irradiator, Blood To Prevent Graft Versus Host Disease
07540146000043Irradiator, Blood To Prevent Graft Versus Host Disease
07540146000029Irradiator, Blood To Prevent Graft Versus Host Disease
07540146000012Irradiator, Blood To Prevent Graft Versus Host Disease
B850033600040Irradiator, Blood To Prevent Graft Versus Host Disease

Maude Adverse Events

SENSE XL TORSO COILPHILIPS HEALTHCARE2014-08-08
RADSOURCEBEST THERATRONICS2010-11-03
RAYCELLBEST THERATARONICS2010-01-07
J.L. SHEPHERD BLOOD IRRADIATORJ.L. SHEPHERD & ASSOCIATES2009-08-06
RADSUREISP TECHNOLOGIES, INC.1998-03-27
ORIS BLOOD IRRADIATORCIS-US INC.1997-05-23
ULTRAVIOLET IRRADIATORFOUNDATION FOR BLOOD IRRADIATION1996-05-09

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.