| 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 |
| 00843511128180 - Omnia Medical TiBrid™- A/SA | 2025-04-07 ALIF Spreader |
| 00843511128241 - Omnia Medical TiBrid™- A/SA | 2025-04-07 Angled ALIF Spreader |
| 00843511112943 - Omnia Medical Instruments | 2025-03-24 PsiF Mallet with Joint Finder Feature |
| 00843511113155 - Omnia Medical TiBrid™-A | 2025-03-24 ALIF Inserter, 45° |
| 00843511128234 - Omnia Medical Disc Prep Set | 2025-03-24 12.7mm NERVE ROOT RETRACTOR |
| 00843511112905 - Omnia Medical Instruments | 2025-02-11 CURETTE, RIGHT RECTANGLE |
| 00843511112912 - Omnia Medical Instruments | 2025-02-11 CURETTE, LEFT RECTANGLE |
| 00843511112929 - Omnia Medical Instruments | 2025-02-11 CURETTE, CIRCLE |