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" |