| Primary Device ID | 00843511113766 |
| NIH Device Record Key | 5c7c131f-1610-4ca4-ba7d-b0e2cf637ee5 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Omnia Medical PSiFDNA |
| Version Model Number | 11-0P-0002 |
| Catalog Number | 11-0P-0002 |
| 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 |
| Phone | 3044164851 |
| customerservice@omniamedical.com | |
| Phone | 3044164851 |
| customerservice@omniamedical.com | |
| Phone | 3044164851 |
| customerservice@omniamedical.com | |
| Phone | 3044164851 |
| customerservice@omniamedical.com | |
| Phone | 3044164851 |
| customerservice@omniamedical.com | |
| Phone | 3044164851 |
| customerservice@omniamedical.com | |
| Phone | 3044164851 |
| customerservice@omniamedical.com | |
| Phone | 3044164851 |
| customerservice@omniamedical.com | |
| Phone | 3044164851 |
| customerservice@omniamedical.com | |
| Phone | 3044164851 |
| customerservice@omniamedical.com | |
| Phone | 3044164851 |
| customerservice@omniamedical.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00843511113766 [Primary] |
| OUR | Sacroiliac Joint Fixation |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00843511113766]
Moist Heat or Steam Sterilization
[00843511113766]
Moist Heat or Steam Sterilization
[00843511113766]
Moist Heat or Steam Sterilization
[00843511113766]
Moist Heat or Steam Sterilization
[00843511113766]
Moist Heat or Steam Sterilization
[00843511113766]
Moist Heat or Steam Sterilization
[00843511113766]
Moist Heat or Steam Sterilization
[00843511113766]
Moist Heat or Steam Sterilization
[00843511113766]
Moist Heat or Steam Sterilization
[00843511113766]
Moist Heat or Steam Sterilization
[00843511113766]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-09-30 |
| Device Publish Date | 2025-09-22 |
| 00843511128227 | PsiF DNA Staple Tower Cap |
| 00843511122805 | PsiF DNA Instrument Tray |
| 00843511122799 | PsiF DNA Drill |
| 00843511122775 | PsiF DNA Impactor |
| 00843511122768 | PsiF DNA Driver |
| 00843511113766 | PsiF DNA Staple Tower |
| 00843511113759 | PsiF DNA Screw, 44mm |
| 00843511113742 | PsiF DNA Screw, 38mm |
| 00843511113735 | PsiF DNA Screw, 28mm |