TRINIAS
GUDID 04540217068807
SHIMADZU CORPORATION
Stationary angiographic x-ray system, digital| Primary Device ID | 04540217068807 |
| NIH Device Record Key | 4acd4ad1-f283-4a1c-99a8-f6a6b94ef7de |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | TRINIAS |
| Version Model Number | 503-79416-04 |
| 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 | true |
| 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 | 04540217068807 [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 | 2022-06-22 |
| Device Publish Date | 2022-06-14 |
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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