| Primary Device ID | 00843511100537 |
| NIH Device Record Key | b0bf458f-efd1-4cdc-9211-a363582501b2 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Omnia Medical Rotary PLIF |
| Version Model Number | STL-011-008 |
| Catalog Number | STL-011-008 |
| Company DUNS | 079467378 |
| Company Name | OMNIA MEDICAL, LLC |
| 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 | 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 | 3044134851 |
| customerservice@omniamedical.com |
| Angle | 7 degree |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00843511100537 [Primary] |
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00843511100537]
Moist Heat or Steam Sterilization
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2020-02-24 |
| Device Publish Date | 2019-07-08 |
| 00843511100612 | Omnia Medical Rotary PLIF 17mm Parallel |
| 00843511100605 | Omnia Medical Rotary PLIF 15mm Parallel |
| 00843511100599 | Omnia Medical Rotary PLIF 13mm Parallel |
| 00843511100582 | Omnia Medical Rotary PLIF 11mm Parallel |
| 00843511100575 | Omnia Medical Rotary PLIF 9mm Parallel |
| 00843511100568 | Omnia Medical Rotary PLIF 17mm Lordotic |
| 00843511100551 | Omnia Medical Rotary PLIF 15mm Lordotic |
| 00843511100544 | Omnia Medical Rotary PLIF 13mm Lordotic |
| 00843511100537 | Omnia Medical Rotary PLIF 11mm Lordotic |
| 00843511100520 | Omnia Medical Rotary PLIF 9mm Lordotic |