Gammacell

Primary DI
07540146000029
Brand
Gammacell
Company
Best Theratronics Ltd
Model
3000
Device description
Blood Irradiator
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
MOTIrradiator, Blood To Prevent Graft Versus Host Disease

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MOTIrradiator, Blood To Prevent Graft Versus Host DiseaseUnknownU

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K050963000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K050963000GAMMACELL 1000 ELITE AND GAMMACELL 3000 ELANMds Nordion2005-05-20MOT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07540146000029PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07540146000029075401460000297540146000029

GMDN Terms#

Term, Definition table
TermDefinition
Ionizing-radiation blood irradiatorA mains electricity (AC-powered) device assembly designed for the in vitro irradiation of blood and/or blood components with ionizing radiation (e.g., gamma), typically used to treat cancer patients by inactivating lymphocytes and for the prevention of transfusion-associated graft-versus-host diseases. It typically includes a shielded, double encapsulated, long half-life radiation source (e.g., Cesium 137), blood/blood product containers, safety interlocks, a timing mechanism, and a means of retrieving samples.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
243606832
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07540146000012Gammacell10002016-09-24
07540146000043RaycellMk22016-09-24
07540146000104RaycellMK12019-07-16
07540146000036TheratronEquinox2016-10-14
07540146000050AvanzaAvanza2016-10-14
07540146000067GammaBeam1002016-10-14
07540146000074GammaBeam5002016-10-14
00754014600106RaycellMK12019-07-16
00754014600014Gammacell10002016-09-24
00754014600021Gammacell30002016-09-24
00754014600038TheratronEquinox2016-10-14
00754014600052AvanzaAvanza2016-10-14
00754014600069GammaBeam1002016-10-14
00754014600076GammaBeam5002016-10-14
00754014600045RaycellMk22016-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B850033600040RADGIL2GILARDONI SPAMOT2021-06-14
07540146000104RaycellBest Theratronics LtdMOT2019-07-16
00754014600106RaycellBest Theratronics LtdMOT2019-07-16
00860000737005RSRAD SOURCE TECHNOLOGIES, INC.MOT2019-03-29
07540146000012GammacellBest Theratronics LtdMOT2016-09-24
07540146000043RaycellBest Theratronics LtdMOT2016-09-24
00754014600014GammacellBest Theratronics LtdMOT2016-09-24
00754014600021GammacellBest Theratronics LtdMOT2016-09-24
00754014600045RaycellBest Theratronics LtdMOT2016-09-24