| Primary Device ID | 00843511100704 |
| NIH Device Record Key | 49ac764d-9785-4a50-ad3c-6dd6842cd88c |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | PsiF |
| Version Model Number | 01-7P-TRA1 |
| 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 | 00843511100704 [Primary] |
| OJH | Orthopedic Tray |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00843511100704]
Moist Heat or Steam Sterilization
[00843511100704]
Moist Heat or Steam Sterilization
[00843511100704]
Moist Heat or Steam Sterilization
[00843511100704]
Moist Heat or Steam Sterilization
[00843511100704]
Moist Heat or Steam Sterilization
[00843511100704]
Moist Heat or Steam Sterilization
[00843511100704]
Moist Heat or Steam Sterilization
[00843511100704]
Moist Heat or Steam Sterilization
[00843511100704]
Moist Heat or Steam Sterilization
[00843511100704]
Moist Heat or Steam Sterilization
[00843511100704]
Moist Heat or Steam Sterilization
[00843511100704]
Moist Heat or Steam Sterilization
[00843511100704]
Moist Heat or Steam Sterilization
[00843511100704]
Moist Heat or Steam Sterilization
[00843511100704]
Moist Heat or Steam Sterilization
[00843511100704]
Moist Heat or Steam Sterilization
[00843511100704]
Moist Heat or Steam Sterilization
[00843511100704]
Moist Heat or Steam Sterilization
[00843511100704]
Moist Heat or Steam Sterilization
[00843511100704]
Moist Heat or Steam Sterilization
[00843511100704]
Moist Heat or Steam Sterilization
[00843511100704]
Moist Heat or Steam Sterilization
[00843511100704]
Moist Heat or Steam Sterilization
[00843511100704]
Moist Heat or Steam Sterilization
[00843511100704]
Moist Heat or Steam Sterilization
[00843511100704]
Moist Heat or Steam Sterilization
[00843511100704]
Moist Heat or Steam Sterilization
[00843511100704]
Moist Heat or Steam Sterilization
[00843511100704]
Moist Heat or Steam Sterilization
[00843511100704]
Moist Heat or Steam Sterilization
[00843511100704]
Moist Heat or Steam Sterilization
[00843511100704]
Moist Heat or Steam Sterilization
[00843511100704]
Moist Heat or Steam Sterilization
[00843511100704]
Moist Heat or Steam Sterilization
[00843511100704]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-02-28 |
| Device Publish Date | 2020-02-20 |
| 00843511111205 - Omnia Medical TiBrid™-A | 2026-02-09 TiBrid™-A IMPACTOR |
| 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 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() PSIF 86074490 4646388 Live/Registered |
ORTHOCISION, INC. 2013-09-25 |
![]() PSIF 86074461 4646387 Live/Registered |
ORTHOCISION, INC. 2013-09-25 |