| Primary Device ID | 00184360000358 |
| NIH Device Record Key | 81b97793-1b96-4f43-a652-60d8b1026898 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Revolution 45MHz Rotational IVUS Imaging Catheter |
| Version Model Number | 89000 |
| Company DUNS | 853202646 |
| Company Name | Volcarica S.R.L. |
| 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 | true |
| Lot Batch | false |
| Serial Number | true |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00184360000358 [Primary] |
| OBJ | Catheter, Ultrasound, Intravascular |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2019-03-21 |
| Device Publish Date | 2016-08-23 |
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