RADGIL2

Primary DI
B850033600040
Brand
RADGIL2
Company
GILARDONI SPA
Model
RADGIL2 US
Catalog number
03360004
Device description
x rays blood irradiator
Published
2021-06-14
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
K201177000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K201177000RadGil2R3 X-Ray L.L.C2020-08-17MOT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B850033600040PrimaryHIBCC0

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Humidity0 Percent (%) Relative Humidity80 Percent (%) Relative Humidity
Handling Environment Temperature15 Degrees Celsius35 Degrees Celsius
Storage Environment Humidity0 Percent (%) Relative Humidity80 Percent (%) Relative Humidity
Storage Environment Temperature0 Degrees Celsius40 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+39341775011DANIELE.MAGGIONI@GILARDONI.IT

Regulatory Flags#

DUNS number
429002678
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
00754014600014GammacellBest Theratronics LtdMOT2016-09-24
00754014600021GammacellBest Theratronics LtdMOT2016-09-24
00754014600045RaycellBest Theratronics LtdMOT2016-09-24