| Primary Device ID | 00843511111861 |
| NIH Device Record Key | 7b311eed-9ada-45b5-9fb0-45b1a4a9b68b |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Omnia Medical TiBrid™-SA |
| Version Model Number | 17-0A-PLT4 |
| 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 | true |
| 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 |
| Height | 38 Millimeter |
| Height | 38 Millimeter |
| Height | 38 Millimeter |
| Height | 38 Millimeter |
| Height | 38 Millimeter |
| Height | 38 Millimeter |
| Height | 38 Millimeter |
| Height | 38 Millimeter |
| Height | 38 Millimeter |
| Height | 38 Millimeter |
| Height | 38 Millimeter |
| Height | 38 Millimeter |
| Height | 38 Millimeter |
| Height | 38 Millimeter |
| Height | 38 Millimeter |
| Height | 38 Millimeter |
| Height | 38 Millimeter |
| Height | 38 Millimeter |
| Height | 38 Millimeter |
| Height | 38 Millimeter |
| Height | 38 Millimeter |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00843511111861 [Primary] |
| OVD | Intervertebral Fusion Device With Integrated Fixation, Lumbar |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00843511111861]
Moist Heat or Steam Sterilization
[00843511111861]
Moist Heat or Steam Sterilization
[00843511111861]
Moist Heat or Steam Sterilization
[00843511111861]
Moist Heat or Steam Sterilization
[00843511111861]
Moist Heat or Steam Sterilization
[00843511111861]
Moist Heat or Steam Sterilization
[00843511111861]
Moist Heat or Steam Sterilization
[00843511111861]
Moist Heat or Steam Sterilization
[00843511111861]
Moist Heat or Steam Sterilization
[00843511111861]
Moist Heat or Steam Sterilization
[00843511111861]
Moist Heat or Steam Sterilization
[00843511111861]
Moist Heat or Steam Sterilization
[00843511111861]
Moist Heat or Steam Sterilization
[00843511111861]
Moist Heat or Steam Sterilization
[00843511111861]
Moist Heat or Steam Sterilization
[00843511111861]
Moist Heat or Steam Sterilization
[00843511111861]
Moist Heat or Steam Sterilization
[00843511111861]
Moist Heat or Steam Sterilization
[00843511111861]
Moist Heat or Steam Sterilization
[00843511111861]
Moist Heat or Steam Sterilization
[00843511111861]
Moist Heat or Steam Sterilization
[00843511111861]
Moist Heat or Steam Sterilization
[00843511111861]
Moist Heat or Steam Sterilization
[00843511111861]
Moist Heat or Steam Sterilization
[00843511111861]
Moist Heat or Steam Sterilization
[00843511111861]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-06-20 |
| Device Publish Date | 2024-06-12 |
| 00843511128128 | TiBrid™ SA Plastic Sleeve |
| 00843511128111 | TiBrid™ SA Self Drilling Variable Tack, 6.0 x 25mm |
| 00843511128104 | TiBrid™ SA Self Drilling Variable Tack, 6.0 x 20mm |
| 00843511128098 | TiBrid™ SA Self Drilling Variable Tack, 6.0 x 15mm |
| 00843511112899 | TiBrid™-SA PLATE, 38mm, L5-S1 |
| 00843511112882 | TiBrid™-SA PLATE, 36mm, L5-S1 |
| 00843511112875 | TiBrid™-SA PLATE, 34mm, L5-S1 |
| 00843511112868 | TiBrid™-SA PLATE, 32mm, L5-S1 |
| 00843511112851 | TiBrid™-SA PLATE, 30mm, L5-S1 |
| 00843511111861 | TiBrid™-SA PLATE, 38mm, L1-L5 |
| 00843511111854 | TiBrid™-SA PLATE, 36mm, L1-L5 |
| 00843511111847 | TiBrid™-SA PLATE, 34mm, L1-L5 |
| 00843511111830 | TiBrid™-SA PLATE, 32mm, L1-L5 |
| 00843511111823 | TiBrid™-SA PLATE, 30mm, L1-L5 |