| Primary Device ID | 00843511112912 |
| NIH Device Record Key | d4bb4eac-3bda-4a9d-9275-0924c9ef4bac |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Omnia Medical Instruments |
| Version Model Number | 99-5A-CRR2 |
| 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 | 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 | |
| Phone | 3044134851 |
| customerservice@omniamedical.com | |
| Phone | 3044134851 |
| customerservice@omniamedical.com | |
| Phone | 3044134851 |
| customerservice@omniamedical.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00843511112912 [Primary] |
| LXH | Orthopedic Manual Surgical Instrument |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00843511112912]
Moist Heat or Steam Sterilization
[00843511112912]
Moist Heat or Steam Sterilization
[00843511112912]
Moist Heat or Steam Sterilization
[00843511112912]
Moist Heat or Steam Sterilization
[00843511112912]
Moist Heat or Steam Sterilization
[00843511112912]
Moist Heat or Steam Sterilization
[00843511112912]
Moist Heat or Steam Sterilization
[00843511112912]
Moist Heat or Steam Sterilization
[00843511112912]
Moist Heat or Steam Sterilization
[00843511112912]
Moist Heat or Steam Sterilization
[00843511112912]
Moist Heat or Steam Sterilization
[00843511112912]
Moist Heat or Steam Sterilization
[00843511112912]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-02-11 |
| Device Publish Date | 2025-02-03 |
| 00843511121785 | Cervical Tamp |
| 00843511104177 | 1/4" SQ TCL Adapter handle |
| 00843511121280 | Bone Access Cannula |
| 00843511101374 | big handled lenke probe |
| 00843511101367 | Soft Tissue Sleeve |
| 00843511101350 | Bullet nose saddle driver |
| 00843511122829 | Drill Bit |
| 00843511123185 | 1.4mm x 680 mm Nitinol K-Wire |
| 00843511123178 | 1.4mm x 520 mm Nitinol K-Wire |
| 00843511123161 | 1.4mm x 380 mm Nitinol K-Wire |
| 00843511121822 | Universal Joint Awl |
| 00843511122164 | TS-TO HANDLE |
| 00843511112936 | CURETTE, ANGLED CIRCLE |
| 00843511112929 | CURETTE, CIRCLE |
| 00843511112912 | CURETTE, LEFT RECTANGLE |
| 00843511112905 | CURETTE, RIGHT RECTANGLE |