| Primary Device ID | 00843511112608 | 
| NIH Device Record Key | 6e468c99-7f0c-4ffa-94d9-1cca84e65683 | 
| Commercial Distribution Status | In Commercial Distribution | 
| Brand Name | TiBrid-A/SA | 
| Version Model Number | 14-5A-RMV2 | 
| 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 | |
| Phone | 3044134851 | 
| customerservice@omniamedical.com | |
| Phone | 3044134851 | 
| customerservice@omniamedical.com | |
| Phone | 3044134851 | 
| customerservice@omniamedical.com | 
| Device Issuing Agency | Device ID | 
|---|---|
| GS1 | 00843511112608 [Primary] | 
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | 
| Steralize Prior To Use | true | 
| Device Is Sterile | false | 
[00843511112608]
Moist Heat or Steam Sterilization
[00843511112608]
Moist Heat or Steam Sterilization
[00843511112608]
Moist Heat or Steam Sterilization
[00843511112608]
Moist Heat or Steam Sterilization
[00843511112608]
Moist Heat or Steam Sterilization
[00843511112608]
Moist Heat or Steam Sterilization
[00843511112608]
Moist Heat or Steam Sterilization
[00843511112608]
Moist Heat or Steam Sterilization
[00843511112608]
Moist Heat or Steam Sterilization
[00843511112608]
Moist Heat or Steam Sterilization
[00843511112608]
Moist Heat or Steam Sterilization
[00843511112608]
Moist Heat or Steam Sterilization
[00843511112608]
Moist Heat or Steam Sterilization
[00843511112608]
Moist Heat or Steam Sterilization
[00843511112608]
Moist Heat or Steam Sterilization
[00843511112608]
Moist Heat or Steam Sterilization
[00843511112608]
Moist Heat or Steam Sterilization
[00843511112608]
Moist Heat or Steam Sterilization
| Public Version Status | New | 
| Device Record Status | Published | 
| Public Version Number | 1 | 
| Public Version Date | 2024-12-25 | 
| Device Publish Date | 2024-12-17 | 
| 00843511113735 - Omnia Medical PSiFDNA | 2025-09-30 PsiF DNA Screw, 28mm | 
| 00843511113742 - Omnia Medical PSiFDNA | 2025-09-30 PsiF DNA Screw, 38mm | 
| 00843511113759 - Omnia Medical PSiFDNA | 2025-09-30 PsiF DNA Screw, 44mm | 
| 00843511113766 - Omnia Medical PSiFDNA | 2025-09-30 PsiF DNA Staple Tower | 
| 00843511122768 - Omnia Medical PSiFDNA | 2025-09-30 PsiF DNA Driver | 
| 00843511122775 - Omnia Medical PSiFDNA | 2025-09-30 PsiF DNA Impactor | 
| 00843511122799 - Omnia Medical PSiFDNA | 2025-09-30 PsiF DNA Drill | 
| 00843511122805 - Omnia Medical PSiFDNA | 2025-09-30 PsiF DNA Instrument Tray |