| 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 |
| 00843511128142 - Omnia Medical Instruments | 2025-07-23 Soft Tissue Drill Bit Full Round |
| 00843511128258 - Omnia Medical Instruments | 2025-07-23 |
| 00843511128265 - Omnia Medical Instruments | 2025-07-23 TiBrid™ SA S Inserter, for 10, 12, 14mm heights |
| 00843511128272 - Omnia Medical Instruments | 2025-07-23 TiBrid™ SA S-Inserter for 16 and 18 heights |
| 00843511128296 - Omnia Medical Instruments | 2025-07-23 TiBrid SA Tack Inserter, 10mm and 12mm heights |
| 00843511128302 - Omnia Medical Instruments | 2025-07-23 TiBrid SA Tack Inserter, 14mm and 16mm heights |
| 00843511128319 - Omnia Medical Instruments | 2025-07-23 TiBrid SA Tack Inserter, 18mm heights |
| 00843511128326 - TiBrid-SA | 2025-07-23 TiBrid-SA Tack Inserter Driver |