Trinias
GUDID 04540217067015
SHIMADZU CORPORATION
Stationary angiographic x-ray system, digital| Primary Device ID | 04540217067015 |
| NIH Device Record Key | a024d198-6293-43a6-ad3a-7d1425dc4a8b |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Trinias |
| Version Model Number | 563-79863-07 |
| Company DUNS | 690558747 |
| Company Name | SHIMADZU CORPORATION |
| 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 | false |
| OTC Over-The-Counter | false |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 04540217067015 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K203535
FDA Product Code
| OWB | Interventional Fluoroscopic X-Ray System |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-09-27 |
| Device Publish Date | 2021-09-17 |
On-Brand Devices [Trinias]
Trademark Results [Trinias]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 TRINIAS 86707621 4972141 Live/Registered |
SHIMADZU CORPORATION 2015-07-28 |
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