| Primary Device ID | 00843511101350 |
| NIH Device Record Key | 70ff591e-ccf9-45a7-ad74-f5956a21b513 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Omnia Medical Instruments |
| Version Model Number | 02-5S-NDR1 |
| Catalog Number | 02-5S-NDR1 |
| 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 | true |
| 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 | 00843511101350 [Primary] |
| LXH | Orthopedic Manual Surgical Instrument |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00843511101350]
Moist Heat or Steam Sterilization
[00843511101350]
Moist Heat or Steam Sterilization
[00843511101350]
Moist Heat or Steam Sterilization
[00843511101350]
Moist Heat or Steam Sterilization
[00843511101350]
Moist Heat or Steam Sterilization
[00843511101350]
Moist Heat or Steam Sterilization
[00843511101350]
Moist Heat or Steam Sterilization
[00843511101350]
Moist Heat or Steam Sterilization
[00843511101350]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-10-25 |
| Device Publish Date | 2021-10-15 |
| 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 |
| 00843511112943 | PsiF Mallet with Joint Finder Feature |
| 00843511128166 | PsiF Mallet with Joint Finder Feature |
| 00843511128159 | PsiF Mallet with Joint Finder Feature |
| 00843511128135 | PsiF Mallet |
| 00843511123222 | 3.0 mm HEX DRIVER |
| 00843511122850 | 5 mm STIRRUP CURETTE |
| 00843511122713 | 4.0 mm HEX DRIVER |
| 00843511122690 | 2.5 mm HEX DRIVER |
| 00843511122249 | NON-RATCHETING, AXIAL MINI, STANDARD AO ADAPTOR |
| 00843511122232 | Torque Limiting Handle, Axial, 1/4" SQ connection |
| 00843511122201 | TORQUE LIMITING HANDLE. AO CONNECTION |
| 00843511122195 | Ratcheting Mini Axial Handle, AO Connector, Cannulated |
| 00843511122188 | Ratcheting T-Handle, 1/4" SQ Connector |
| 00843511122171 | Ratcheting Axial Handle, 1/4" SQ Connector |
| 00843511122157 | Universal Slap Hammer |
| 00843511121471 | T-Handle Non-Ratcheting, 1/4" |
| 00843511128371 | Soft Tissue Drill Bit Half Round |
| 00843511128340 | TiBrid SA Inserter with SQ connect |
| 00843511128319 | TiBrid SA Tack Inserter, 18mm heights |
| 00843511128302 | TiBrid SA Tack Inserter, 14mm and 16mm heights |
| 00843511128296 | TiBrid SA Tack Inserter, 10mm and 12mm heights |
| 00843511128272 | TiBrid™ SA S-Inserter for 16 and 18 heights |
| 00843511128265 | TiBrid™ SA S Inserter, for 10, 12, 14mm heights |
| 00843511128258 | 99-5A-CPP1 |
| 00843511128142 | Soft Tissue Drill Bit Full Round |