| Primary Device ID | 10810170012126 |
| NIH Device Record Key | 54ad91ec-7f1a-414e-80e2-c6114805df0a |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Azur Detachment Controller |
| Version Model Number | 45-4001 |
| Catalog Number | 45-4001 |
| Company DUNS | 003263105 |
| Company Name | MICROVENTION INC. |
| Device Count | 1 |
| DM Exempt | true |
| Pre-market Exempt | false |
| MRI Safety Status | MR Conditional |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| 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 Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
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| Device Size Text, specify | 0 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00810170012129 [Primary] |
| GS1 | 10810170012126 [Package] Contains: 00810170012129 Package: Carton [5 Units] In Commercial Distribution |
| KRD | Device, Vascular, for Promoting Embolization |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2018-03-29 |
| Device Publish Date | 2016-09-24 |
| 00842429108444 - Sofia | 2024-10-28 Sofia 6F-115cm STR |
| 00842429108451 - Sofia | 2024-10-28 Sofia 6F-125cm STR |
| 00842429108468 - Sofia | 2024-10-28 Sofia 6F-131cm STR |
| 00842429108475 - Sofia | 2024-10-28 Sofia 6F-125cm STR |
| 00842429118092 - Access | 2024-10-28 Sofia EX 5F - 115cm STR |
| 00842429119396 - Wedge | 2024-10-28 Wedge XL |
| 00842429108482 - Sofia | 2024-08-14 Sofia 6F-131cm STR |
| 00842429117705 - SOFIA 88 | 2023-06-23 SOFIA 88 - 115cm |