| Primary Device ID | 00843511122126 | 
| NIH Device Record Key | 7af3620c-0f16-40c7-b5f0-1df5412ee781 | 
| Commercial Distribution Status | In Commercial Distribution | 
| Brand Name | Omnia Medical TiBrid™-A / SA | 
| Version Model Number | 17-8A-TRY4 | 
| 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 | false | 
| 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 | |
| Phone | 3044134851 | 
| customerservice@omniamedical.com | |
| Phone | 3044134851 | 
| customerservice@omniamedical.com | |
| Phone | 3044134851 | 
| customerservice@omniamedical.com | |
| Phone | 3044134851 | 
| customerservice@omniamedical.com | |
| Phone | 3044134851 | 
| customerservice@omniamedical.com | |
| Phone | 3044134851 | 
| customerservice@omniamedical.com | |
| Phone | 3044134851 | 
| customerservice@omniamedical.com | |
| Phone | 3044134851 | 
| customerservice@omniamedical.com | |
| Phone | 3044134851 | 
| customerservice@omniamedical.com | |
| Phone | 3044134851 | 
| customerservice@omniamedical.com | |
| Phone | 3044134851 | 
| customerservice@omniamedical.com | |
| Phone | 3044134851 | 
| customerservice@omniamedical.com | |
| Phone | 3044134851 | 
| customerservice@omniamedical.com | |
| Phone | 3044134851 | 
| customerservice@omniamedical.com | 
| Device Issuing Agency | Device ID | 
|---|---|
| GS1 | 00843511122126 [Primary] | 
| OVD | Intervertebral Fusion Device With Integrated Fixation, Lumbar | 
| Steralize Prior To Use | true | 
| Device Is Sterile | false | 
[00843511122126]
Moist Heat or Steam Sterilization
[00843511122126]
Moist Heat or Steam Sterilization
[00843511122126]
Moist Heat or Steam Sterilization
[00843511122126]
Moist Heat or Steam Sterilization
[00843511122126]
Moist Heat or Steam Sterilization
[00843511122126]
Moist Heat or Steam Sterilization
[00843511122126]
Moist Heat or Steam Sterilization
[00843511122126]
Moist Heat or Steam Sterilization
[00843511122126]
Moist Heat or Steam Sterilization
[00843511122126]
Moist Heat or Steam Sterilization
[00843511122126]
Moist Heat or Steam Sterilization
[00843511122126]
Moist Heat or Steam Sterilization
[00843511122126]
Moist Heat or Steam Sterilization
[00843511122126]
Moist Heat or Steam Sterilization
[00843511122126]
Moist Heat or Steam Sterilization
| Public Version Status | New | 
| Device Record Status | Published | 
| Public Version Number | 1 | 
| Public Version Date | 2024-05-16 | 
| Device Publish Date | 2024-05-08 | 
| 00843511122133 | TiBrid ALIF/SA Tray | 
| 00843511122126 | TiBrid ALIF/SA Tray |