| Primary Device ID | 00843511123154 |
| NIH Device Record Key | 6d87616e-9b78-4fe4-a8fe-ec357d00ca05 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Omnia Medical TiBrid™- A/SA |
| Version Model Number | 17-5A-BTI1 |
| Catalog Number | 21-5L-INS6 |
| Company DUNS | 079467378 |
| Company Name | OMNIA MEDICAL, LLC |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00843511123154 [Primary] |
| LXH | Orthopedic Manual Surgical Instrument |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00843511123154]
Moist Heat or Steam Sterilization
[00843511123154]
Moist Heat or Steam Sterilization
[00843511123154]
Moist Heat or Steam Sterilization
[00843511123154]
Moist Heat or Steam Sterilization
[00843511123154]
Moist Heat or Steam Sterilization
[00843511123154]
Moist Heat or Steam Sterilization
[00843511123154]
Moist Heat or Steam Sterilization
[00843511123154]
Moist Heat or Steam Sterilization
[00843511123154]
Moist Heat or Steam Sterilization
[00843511123154]
Moist Heat or Steam Sterilization
[00843511123154]
Moist Heat or Steam Sterilization
[00843511123154]
Moist Heat or Steam Sterilization
[00843511123154]
Moist Heat or Steam Sterilization
[00843511123154]
Moist Heat or Steam Sterilization
[00843511123154]
Moist Heat or Steam Sterilization
[00843511123154]
Moist Heat or Steam Sterilization
[00843511123154]
Moist Heat or Steam Sterilization
[00843511123154]
Moist Heat or Steam Sterilization
[00843511123154]
Moist Heat or Steam Sterilization
[00843511123154]
Moist Heat or Steam Sterilization
[00843511123154]
Moist Heat or Steam Sterilization
[00843511123154]
Moist Heat or Steam Sterilization
[00843511123154]
Moist Heat or Steam Sterilization
[00843511123154]
Moist Heat or Steam Sterilization
[00843511123154]
Moist Heat or Steam Sterilization
[00843511123154]
Moist Heat or Steam Sterilization
[00843511123154]
Moist Heat or Steam Sterilization
[00843511123154]
Moist Heat or Steam Sterilization
[00843511123154]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-10-26 |
| Device Publish Date | 2023-10-18 |
| 00843511123154 | Bullet Trial Inserter |
| 00843511123147 | TiBrid™-SA Bullet Trial, 14mm |
| 00843511123130 | TiBrid™-SA Bullet Trial, 13mm |
| 00843511123123 | TiBrid™-SA Bullet Trial, 12mm |
| 00843511123116 | TiBrid™-SA Bullet Trial, 11mm |
| 00843511123109 | TiBrid™-SA Bullet Trial, 10mm |
| 00843511123093 | TiBrid™-SA Bullet Trial, 9mm |
| 00843511123086 | TiBrid™-SA Bullet Trial, 8mm |
| 00843511123079 | Omnia Medical TiBrid-A Trial Caddy 40mm |
| 00843511123062 | Omnia Medical TiBrid-A Trial Caddy 36mm |
| 00843511123055 | Omnia Medical TiBrid-A Trial Caddy 32mm |
| 00843511123048 | Omnia Medical TiBrid-A Rasp Caddy 40mm |
| 00843511123031 | Omnia Medical TiBrid-A Rasp Caddy 36mm |
| 00843511123024 | Omnia Medical TiBrid-A Rasp Caddy 32mm |
| 00843511128241 | Angled ALIF Spreader |
| 00843511128180 | ALIF Spreader |