| Primary Device ID | 03613720193678 |
| NIH Device Record Key | aba46207-b49b-4083-b838-75782041229a |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | IMPIX ALIF D |
| Version Model Number | B15121812 |
| Catalog Number | B15121812 |
| Company DUNS | 383228632 |
| Company Name | MEDICREA INTERNATIONAL |
| 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 | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 03613720193678 [Primary] |
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 5 |
| Public Version Date | 2020-08-06 |
| Device Publish Date | 2015-10-24 |
| 03613720193678 | IMPIX-ALIF D 18mm at 12° |
| 03613720193654 | IMPIX-ALIF D 18mm at 6° |
| 03613720193647 | IMPIX-ALIF D 16mm at 12° |
| 03613720193630 | IMPIX-ALIF D 16mm at 9° |
| 03613720193623 | IMPIX-ALIF D 16mm at 6° |
| 03613720193616 | IMPIX-ALIF D 14mm at 12° |
| 03613720193609 | IMPIX-ALIF D 14mm at 9° |
| 03613720193593 | IMPIX-ALIF D 14mm at 6° |
| 03613720193586 | IMPIX-ALIF D 12mm at 12° |
| 03613720193579 | IMPIX-ALIF D 12mm at 9° |
| 03613720193562 | IMPIX-ALIF D 12mm at 6° |
| 03613720193555 | IMPIX-ALIF D 10mm at 12° |
| 03613720193548 | IMPIX-ALIF D 10mm at 9° |
| 03613720193531 | IMPIX-ALIF D 10mm at 6° |