| Primary Device ID | 00843511100728 |
| NIH Device Record Key | 0f307cd5-960d-4875-9fd7-8b0346f5ceda |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Pedicle Screw |
| Version Model Number | 19-6A-PSRT |
| Catalog Number | 19-6A-PSRT |
| 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 |
| Phone | 3044134851 |
| customerservice@omniamedical.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00843511100728 [Primary] |
| HXX | Screwdriver |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00843511100728]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-03-10 |
| Device Publish Date | 2020-03-02 |
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