Gammacell
GUDID 07540146000012
Blood Irradiator
Best Theratronics Ltd
Ionizing-radiation blood irradiator| Primary Device ID | 07540146000012 |
| NIH Device Record Key | 967042ad-577e-43d4-9be0-59685250b2be |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Gammacell |
| Version Model Number | 1000 |
| Company DUNS | 243606832 |
| Company Name | Best Theratronics Ltd |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | false |
| Serial Number | true |
| Manufacturing Date | true |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 07540146000012 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K050963
FDA Product Code
| MOT | Irradiator, Blood To Prevent Graft Versus Host Disease |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2020-01-20 |
| Device Publish Date | 2016-09-24 |
On-Brand Devices [Gammacell]
| 00754014600021 | Blood Irradiator |
| 00754014600014 | Blood Irradiator |
| 07540146000029 | Blood Irradiator |
| 07540146000012 | Blood Irradiator |
Trademark Results [Gammacell]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 GAMMACELL 73578824 1430119 Live/Registered |
ATOMIC ENERGY OF CANADA LIMITED 1986-01-21 |
 GAMMACELL 73530888 1387298 Live/Registered |
ATOMIC ENERGY OF CANADA LIMITED 1985-04-05 |
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