| Primary Device ID | 03613720193760 |
| NIH Device Record Key | 33885b70-243f-4ff0-afed-b00239e2cc3a |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | IMPIX TLIF |
| Version Model Number | B15130611S |
| Catalog Number | B15130611S |
| 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 | 03613720193760 [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 | 2020-08-07 |
| Device Publish Date | 2015-10-23 |
| 03613720245681 | IMPIX-TLIF LUMBAR CAGE 7mm - 6° |
| 03613720245674 | LUMBAR CAGE IMPIX-TLIF 9mm - 6° |
| 03613720193814 | LUMBAR CAGE IMPIX-TLIF 17mm - 6° |
| 03613720193807 | LUMBAR CAGE IMPIX-TLIF 15mm - 6° |
| 03613720193791 | LUMBAR CAGE IMPIX-TLIF 15mm - 6° |
| 03613720193784 | LUMBAR CAGE IMPIX-TLIF 13mm - 6° |
| 03613720193777 | LUMBAR CAGE IMPIX-TLIF 13mm - 6° |
| 03613720193760 | LUMBAR CAGE IMPIX-TLIF 11mm - 6° |
| 03613720193753 | LUMBAR CAGE IMPIX-TLIF 11mm - 6° |
| 03613720193739 | LUMBAR CAGE IMPIX-TLIF 9mm - 6° |
| 03613720193715 | IMPIX-TLIF LUMBAR CAGE 7mm at 6° |