| Primary Device ID | 00845225001278 |
| NIH Device Record Key | c4275f05-5bde-4b29-b497-8181e75a95b5 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Eagle Eye Platinum Digital IVUS Catheter |
| Version Model Number | 85900P |
| 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 |
| Length | 150 Centimeter |
| Length | 150 Centimeter |
| Length | 150 Centimeter |
| Length | 150 Centimeter |
| Length | 150 Centimeter |
| Length | 150 Centimeter |
| Length | 150 Centimeter |
| Length | 150 Centimeter |
| Length | 150 Centimeter |
| Length | 150 Centimeter |
| Length | 150 Centimeter |
| Length | 150 Centimeter |
| Length | 150 Centimeter |
| Length | 150 Centimeter |
| Length | 150 Centimeter |
| Length | 150 Centimeter |
| Length | 150 Centimeter |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00845225001278 [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 |
| 00845225003029 - VeriSight (2D) ICE Catheter | 2020-09-23 The VeriSight/VeriSight Pro ICE Catheter is intended for intracardiac and intra-luminal visualization of cardiac and great vesse |
| 00845225003036 - VeriSight Pro (3D) ICE Catheter | 2020-09-23 The VeriSight/VeriSight Pro ICE Catheter is intended for intracardiac and intra-luminal visualization of cardiac and great vesse |
| 00845225003043 - OmniWire Pressure Guide Wire, Straight Tip | 2020-04-28 The OmniWire pressure guide wire is indicated for use to measure pressure in blood vessels, including both coronary and peripher |
| 00845225003050 - OmniWire Pressure Guide Wire, J-Tip | 2020-04-28 The OmniWire pressure guide wire is indicated for use to measure pressure in blood vessels, including both coronary and peripher |
| 00845225002596 - Visions PV .035, 90 CM, US Digital IVUS Catheter | 2020-01-01 |
| 00845225001278 - Eagle Eye Platinum Digital IVUS Catheter | 2019-03-21 |
| 00845225001278 - Eagle Eye Platinum Digital IVUS Catheter | 2019-03-21 |
| 00845225002312 - Eagle Eye Platinum ST Digital IVUS Catheter | 2019-03-21 |
| 00845225002329 - Visions PV .035 Digital IVUS Catheter | 2019-03-21 |