Raycell

GUDID 00754014600106

Blood Irradiator

Best Theratronics Ltd

Ionizing-radiation blood irradiator
Primary Device ID00754014600106
NIH Device Record Key8868cdb3-8d33-4cda-affe-d5a63f65526b
Commercial Distribution StatusIn Commercial Distribution
Brand NameRaycell
Version Model NumberMK1
Company DUNS243606832
Company NameBest Theratronics Ltd
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone(613)5912100
Emailcompliance@theratronics.ca

Device Identifiers

Device Issuing AgencyDevice ID
GS100754014600106 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MOTIrradiator, Blood To Prevent Graft Versus Host Disease

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-07-24
Device Publish Date2019-07-16

On-Brand Devices [Raycell]

00754014600045Blood Irradiator
00754014600106Blood Irradiator
07540146000104Blood Irradiator
07540146000043Blood Irradiator

Trademark Results [Raycell]

Mark Image

Registration | Serial
Company
Trademark
Application Date
RAYCELL
RAYCELL
87555854 5471426 Live/Registered
Hebei Yafei Leather Manufacturing Co,Ltd.
2017-08-04
RAYCELL
RAYCELL
76581218 3500500 Live/Registered
BEST THERATRONICS LTD.
2004-03-16
RAYCELL
RAYCELL
74026137 not registered Dead/Abandoned
Guilford Mills, Inc.
1990-02-06

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