Gammacell

Primary DI
00754014600014
Brand
Gammacell
Company
Best Theratronics Ltd
Model
1000
Device description
Blood Irradiator
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does n
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

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
00754014600014PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00754014600014007540146000147540146000140754014600014

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

Contacts#

Phone, Email table
PhoneEmail
6135912100compliance@theratronics.ca

Regulatory Flags#

DUNS number
243606832
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07540146000012Gammacell10002016-09-24
07540146000029Gammacell30002016-09-24
07540146000043RaycellMk22016-09-24
07540146000104RaycellMK12019-07-16
07540146000036TheratronEquinox2016-10-14
07540146000050AvanzaAvanza2016-10-14
07540146000067GammaBeam1002016-10-14
07540146000074GammaBeam5002016-10-14
00754014600106RaycellMK12019-07-16
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
07540146000029GammacellBest Theratronics LtdMOT2016-09-24
07540146000043RaycellBest Theratronics LtdMOT2016-09-24
00754014600021GammacellBest Theratronics LtdMOT2016-09-24
00754014600045RaycellBest Theratronics LtdMOT2016-09-24