| Primary Device ID | 00843511123338 |
| NIH Device Record Key | 3f4f1cb5-e2cf-49de-8abf-863586d9c6d7 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Omnia Medical PsiF |
| Version Model Number | 11-14-S300-BT |
| 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 | 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 |
| Length | 300 Millimeter |
| Length | 300 Millimeter |
| Length | 300 Millimeter |
| Length | 300 Millimeter |
| Length | 300 Millimeter |
| Length | 300 Millimeter |
| Length | 300 Millimeter |
| Length | 300 Millimeter |
| Length | 300 Millimeter |
| Length | 300 Millimeter |
| Length | 300 Millimeter |
| Length | 300 Millimeter |
| Length | 300 Millimeter |
| Length | 300 Millimeter |
| Length | 300 Millimeter |
| Length | 300 Millimeter |
| Length | 300 Millimeter |
| Length | 300 Millimeter |
| Length | 300 Millimeter |
| Length | 300 Millimeter |
| Length | 300 Millimeter |
| Length | 300 Millimeter |
| Length | 300 Millimeter |
| Length | 300 Millimeter |
| Length | 300 Millimeter |
| Length | 300 Millimeter |
| Length | 300 Millimeter |
| Length | 300 Millimeter |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00843511123338 [Primary] |
| LXH | Orthopedic Manual Surgical Instrument |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00843511123338]
Moist Heat or Steam Sterilization
[00843511123338]
Moist Heat or Steam Sterilization
[00843511123338]
Moist Heat or Steam Sterilization
[00843511123338]
Moist Heat or Steam Sterilization
[00843511123338]
Moist Heat or Steam Sterilization
[00843511123338]
Moist Heat or Steam Sterilization
[00843511123338]
Moist Heat or Steam Sterilization
[00843511123338]
Moist Heat or Steam Sterilization
[00843511123338]
Moist Heat or Steam Sterilization
[00843511123338]
Moist Heat or Steam Sterilization
[00843511123338]
Moist Heat or Steam Sterilization
[00843511123338]
Moist Heat or Steam Sterilization
[00843511123338]
Moist Heat or Steam Sterilization
[00843511123338]
Moist Heat or Steam Sterilization
[00843511123338]
Moist Heat or Steam Sterilization
[00843511123338]
Moist Heat or Steam Sterilization
[00843511123338]
Moist Heat or Steam Sterilization
[00843511123338]
Moist Heat or Steam Sterilization
[00843511123338]
Moist Heat or Steam Sterilization
[00843511123338]
Moist Heat or Steam Sterilization
[00843511123338]
Moist Heat or Steam Sterilization
[00843511123338]
Moist Heat or Steam Sterilization
[00843511123338]
Moist Heat or Steam Sterilization
[00843511123338]
Moist Heat or Steam Sterilization
[00843511123338]
Moist Heat or Steam Sterilization
[00843511123338]
Moist Heat or Steam Sterilization
[00843511123338]
Moist Heat or Steam Sterilization
[00843511123338]
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 |
| 00843511100681 | PsiF Impaction Cap Ball Handle |
| 00843511100674 | PsiF Joint Finder Instrument |
| 00843511100667 | PsiF Cannula Instrument |
| 00843511100650 | PsiF Box Cutter Rasp Instrument |
| 00843511100643 | PsiF Slap Hammer Peg Instrument |
| 00843511100636 | PsiF Post Packer (Long Impactor) Instrument |
| 00843511100629 | PsiF Allograft Inserter Instrument |
| 00843511101251 | PsiF Impaction Cap Handle |
| 00843511100902 | Orthocision PsiF Box Cutter |
| 00843511101336 | 1.4 mm x 130 mm Kwire |
| 00843511121778 | Kwire, 1.4mm x 460 mm Nitinol, blunt drill |
| 00843511121266 | Impaction Cap Handle |
| 00843511121228 | Joint finder |
| 00843511121242 | Drill Adapter |
| 00843511123383 | Psif DNA and 90 Joint Finder Single use Aluminum |
| 00843511123338 | 300 mm Stainless K-wire, blunt tip |
| 00843511123321 | 230 mm Stainless K-wire, blunt tip |
| 00843511123314 | 200 mm Stainless K-wire, blunt tip |
| 00843511123307 | 180 mm Stainless K-wire, blunt tip |