| Primary Device ID | 00847536031975 |
| NIH Device Record Key | 55f60ee9-8650-4ac3-b2c7-028c3c1aa3fb |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Axium PrimeTM |
| Version Model Number | APB-3.5-10-3D-ES |
| Company DUNS | 826110710 |
| Company Name | Micro Therapeutics, Inc. |
| Device Count | 1 |
| DM Exempt | false |
| 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 | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight, Store product in a dry, cool place. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight, Store product in a dry, cool place. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight, Store product in a dry, cool place. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight, Store product in a dry, cool place. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight, Store product in a dry, cool place. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight, Store product in a dry, cool place. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight, Store product in a dry, cool place. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight, Store product in a dry, cool place. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight, Store product in a dry, cool place. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight, Store product in a dry, cool place. |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00847536031975 [Primary] |
| KRD | Device, Vascular, for Promoting Embolization |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2019-06-28 |
| Device Publish Date | 2019-06-20 |
| 00847536034488 | COIL FC-25-50-3D V03 |
| 00847536034471 | COIL FC-22-50-3D V03 |
| 00847536034464 | COIL FC-20-50-3D V03 |
| 00847536034457 | COIL FC-18-50-3D V03 |
| 00847536034440 | COIL FC-18-40-3D V03 |
| 00847536034433 | COIL FC-16-50-3D V03 |
| 00847536034426 | COIL FC-16-40-3D V03 |
| 00847536034419 | COIL FC-14-50-3D V03 |
| 00847536034402 | COIL FC-14-40-3D V03 |
| 00847536034396 | COIL FC-14-30-3D V03 |
| 00847536034389 | COIL FC-12-50-3D V03 |
| 00847536034372 | COIL FC-12-40-3D V03 |
| 00847536034365 | COIL FC-12-30-3D V03 |
| 00847536034358 | COIL FC-10-40-3D V03 |
| 00847536034341 | COIL FC-10-30-3D V03 |
| 00847536034334 | COIL FC-10-20-3D V03 |
| 00847536034327 | COIL FC-9-30-3D V03 |
| 00847536034310 | COIL FC-9-20-3D V03 |
| 00847536034303 | COIL FC-8-30-3D V03 |
| 00847536034297 | COIL FC-8-20-3D V03 |
| 00847536034280 | COIL FC-8-15-3D V03 |
| 00847536034273 | COIL FC-7-30-3D V03 |
| 00847536034266 | COIL FC-7-20-3D V03 |
| 00847536034259 | COIL FC-7-15-3D V03 |
| 00847536034242 | COIL FC-7-12-3D V03 |
| 00847536034235 | COIL FC-6-25-3D V03 |
| 00847536034228 | COIL FC-6-20-3D V03 |
| 00847536034211 | COIL FC-6-15-3D V03 |
| 00847536034204 | COIL FC-6-10-3D V03 |
| 00847536034198 | COIL FC-5-20-3D V03 |
| 00847536034181 | COIL FC-5-15-3D V03 |
| 00847536034174 | COIL FC-5-10-3D V03 |
| 00847536034167 | COIL FC-5-8-3D V03 |
| 00847536034150 | COIL FC-4-15-3D V03 |
| 00847536034143 | COIL FC-4-12-3D V03 |
| 00847536034136 | COIL FC-4-10-3D V03 |
| 00847536034129 | COIL FC-4-8-3D V03 |
| 00847536034112 | COIL FC-4-6-3D V03 |
| 00847536034105 | COIL FC-3.5-10-3D V03 |
| 00847536034099 | COIL FC-3.5-8-3D V03 |
| 00847536034082 | COIL FC-3.5-6-3D V03 |
| 00847536034075 | COIL FC-3-10-3D V03 |
| 00847536034068 | COIL FC-3-8-3D V03 |
| 00847536034051 | COIL FC-3-6-3D V03 |
| 00847536032378 | COIL APB-6-20-HX-SS V04 |
| 00847536032361 | COIL APB-6-12-HX-SS V04 |
| 00847536032354 | COIL APB-5-20-HX-SS V04 |
| 00847536032347 | COIL APB-5-15-HX-SS V04 |
| 00847536032330 | COIL APB-5-10-HX-SS V04 |
| 00847536032323 | COIL APB-4-12-HX-SS V04 |