| Primary Device ID | 00843511128173 |
| NIH Device Record Key | 305deec5-d8d4-4d5e-8f2f-5d6c94c15a88 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Omnia Medical Golden Spike |
| Version Model Number | 21-5L-INS7 |
| Catalog Number | 21-5L-INS7 |
| 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 | |
| Phone | 3044134851 |
| customerservice@omniamedical.com | |
| Phone | 3044134851 |
| customerservice@omniamedical.com | |
| Phone | 3044134851 |
| customerservice@omniamedical.com | |
| Phone | 3044134851 |
| customerservice@omniamedical.com | |
| Phone | 3044134851 |
| customerservice@omniamedical.com | |
| Phone | 3044134851 |
| customerservice@omniamedical.com | |
| Phone | 3044134851 |
| customerservice@omniamedical.com | |
| Phone | 3044134851 |
| customerservice@omniamedical.com | |
| Phone | 3044134851 |
| customerservice@omniamedical.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00843511128173 [Primary] |
| LXH | Orthopedic Manual Surgical Instrument |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00843511128173]
Moist Heat or Steam Sterilization
[00843511128173]
Moist Heat or Steam Sterilization
[00843511128173]
Moist Heat or Steam Sterilization
[00843511128173]
Moist Heat or Steam Sterilization
[00843511128173]
Moist Heat or Steam Sterilization
[00843511128173]
Moist Heat or Steam Sterilization
[00843511128173]
Moist Heat or Steam Sterilization
[00843511128173]
Moist Heat or Steam Sterilization
[00843511128173]
Moist Heat or Steam Sterilization
[00843511128173]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-11-29 |
| Device Publish Date | 2024-11-21 |
| 00843511100872 | 4.0 x 50mm Trauma Screw |
| 00843511100865 | 4.0 x 48mm Trauma Screw |
| 00843511100858 | 4.0 x 46mm Trauma Screw |
| 00843511100841 | 4.0 x 44mm Trauma Screw |
| 00843511100834 | 4.0 x 42mm Trauma Screw |
| 00843511100827 | 4.0 x 40mm Trauma Screw |
| 00843511100810 | 4.0 x 38mm Trauma Screw |
| 00843511100803 | 4.0 x 36mm Trauma Screw |
| 00843511100797 | 4.0 x 34mm Trauma Screw |
| 00843511100780 | 4.0 x 32mm Trauma Screw |
| 00843511100773 | 4.0 x 30mm Trauma Screw |
| 00843511100766 | 4.0 x 28mm Trauma Screw |
| 00843511100759 | 4.0 x 26mm Trauma Screw |
| 00843511121761 | Screw inserter |
| 00843511123017 | 4.0 x 50mm Threaded Trauma Screw |
| 00843511123000 | 4.0 x 48mm Threaded Trauma Screw |
| 00843511122997 | 4.0 x 46mm Threaded Trauma Screw |
| 00843511122980 | 4.0 x 44mm Threaded Trauma Screw |
| 00843511122973 | 4.0 x 42mm Threaded Trauma Screw |
| 00843511122966 | 4.0 x 40mm Threaded Trauma Screw |
| 00843511122959 | 4.0 x 38mm Threaded Trauma Screw |
| 00843511122942 | 4.0 x 36mm Threaded Trauma Screw |
| 00843511122935 | 4.0 x 34mm Threaded Trauma Screw |
| 00843511122928 | 4.0 x 32mm Threaded Trauma Screw |
| 00843511122911 | 4.0 x 30mm Threaded Trauma Screw |
| 00843511122904 | 4.0 x 28mm Threaded Trauma Screw |
| 00843511122898 | 4.0 x 26mm Threaded Trauma Screw |
| 00843511122867 | Threaded Screw Inserter |
| 00843511122843 | Split Tip Inserter |
| 00843511123208 | Threaded TLS Screw Inserter - AO Connection |
| 00843511128173 | Golden Spike Driver, not threaded |