| 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 |