Primary Device ID | 00840916111472 |
NIH Device Record Key | 8df12fcf-490d-4384-88f0-574eec24d67c |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Omni |
Version Model Number | ST05040 |
Company DUNS | 004022104 |
Company Name | SPINAL ELEMENTS |
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 | true |
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 |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00840916111472 [Primary] |
MNI | Orthosis, Spinal Pedicle Fixation |
Steralize Prior To Use | true |
Device Is Sterile | false |
[00840916111472]
Moist Heat or Steam Sterilization
[00840916111472]
Moist Heat or Steam Sterilization
[00840916111472]
Moist Heat or Steam Sterilization
[00840916111472]
Moist Heat or Steam Sterilization
[00840916111472]
Moist Heat or Steam Sterilization
[00840916111472]
Moist Heat or Steam Sterilization
[00840916111472]
Moist Heat or Steam Sterilization
[00840916111472]
Moist Heat or Steam Sterilization
[00840916111472]
Moist Heat or Steam Sterilization
[00840916111472]
Moist Heat or Steam Sterilization
[00840916111472]
Moist Heat or Steam Sterilization
[00840916111472]
Moist Heat or Steam Sterilization
[00840916111472]
Moist Heat or Steam Sterilization
[00840916111472]
Moist Heat or Steam Sterilization
[00840916111472]
Moist Heat or Steam Sterilization
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 5 |
Public Version Date | 2020-03-25 |
Device Publish Date | 2017-07-10 |
00840916111489 | 5.0mm x 45mm Lo-Top Talon Screw |
00840916111472 | 5.0mm x 40mm Lo-Top Talon Screw |
00840916109950 | 7.0mm x 45mm Reduction Tab Screw |
00840916108212 | 120mm 360 Flex Bullet Rod |
00840916108182 | 110mm 360 Flex Bullet Rod |
00840916108168 | 100mm 360 Flex Bullet Rod |
00840916110598 | 5.5mm x 120mm Straight Rod (00607-120) |
00840916110192 | 4.5mm x 35mm Polyaxial Screw |
00840916110185 | 4.5mm x 30mm Polyaxial Screw |
00840916108601 | 6.0x55mm Long Cannulated Screw |
00840916108595 | 6.0x50mm Long Cannulated Screw |
00840916108564 | 6.0x35mm Long Cannulated Screw |
00840916111045 | 5.5mm x 30mm Prebent Rod |
00840916111038 | 60-75 (Lg) Cross Connector |
00840916110765 | 50mm Barrel 5.5mm Pre-Bent Rod |
00840916110703 | 35mm Flex 5.5mm Pre-Bent Rod |
00840916110680 | 5.5x600mm Straight Rod |
00840916110673 | 5.5x500mm Straight Rod |
00840916110611 | 5.5mm x 140mm Straight Rod (00607-140) |
00840916110604 | 5.5mm x 130mm Straight Rod |
00840916110581 | 5.5mm x 110mm Straight Rod |
00840916110574 | 5.5mm x 100mm Straight Rod (00607-100) |
00840916110482 | Lock Screw Assembly |
00840916110215 | 4.5mm x 45mm Polyaxial Screw |
00840916110161 | 4.0mm x 40mm Polyaxial Screw |
00840916109820 | Keyed Bullet Rod 30mm |
00840916108922 | 95mm 360 Flex Pre-Bent Bullet |
00840916108915 | 95mm 360 Flex Bullet Rod |
00840916108908 | 90mm Keyed Bullet Rod |
00840916108892 | 90mm 360 Flex Pre-Bent Bullet |
00840916108885 | 90mm 360 Flex Bullet Rod |
00840916108878 | 85mm 360 Flex Pre-Bent Bullet |
00840916108861 | 85mm 360 Flex Bullet Rod |
00840916108854 | 80mm Keyed Bullet Rod |
00840916108847 | 80mm 360 Flex Pre-Bent Bullet |
00840916108830 | 80mm 360 Flex Bullet Rod |
00840916108823 | 8.0 x 50mm Long Cannulated Screw |
00840916108816 | 8.0 x 45mm Long Cannulated Screw |
00840916108809 | 8.0 x 40mm Long Cannulated Screw |
00840916108793 | 8.0 x 35mm Long Cannulated Screw |
00840916108755 | 70mm Keyed Bullet Rod |
00840916108748 | 70mm 360 Flex Pre-Bent Bullet |
00840916108731 | 70mm 360 Flex Bullet Rod |
00840916108724 | 7.0x55mm Long Cannulated Screw |
00840916108717 | 7.0x50mm Long Cannulated Screw |
00840916108700 | 7.0x45mm Long Cannulated Screw |
00840916108694 | 7.0x40mm Long Cannulated Screw |
00840916108687 | 7.0x35mm Long Cannulated Screw |
00840916108670 | 70mm Bullet Rod |
00840916108632 | 60mm Keyed Bullet Rod |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
OMNI 98504606 not registered Live/Pending |
OmniOrder 2024-04-17 |
OMNI 98408810 not registered Live/Pending |
Canby Telephone Association 2024-02-16 |
OMNI 98408809 not registered Live/Pending |
Canby Telephone Association 2024-02-16 |
OMNI 98382458 not registered Live/Pending |
Universal Instruments Corporation 2024-01-30 |
OMNI 98374513 not registered Live/Pending |
Tractian LLC 2024-01-24 |
OMNI 98323987 not registered Live/Pending |
IVISION TECH INC. 2023-12-20 |
OMNI 98294861 not registered Live/Pending |
IVISION TECH, Inc. 2023-12-01 |
OMNI 98292411 not registered Live/Pending |
ChargePoint, Inc. 2023-11-30 |
OMNI 98291159 not registered Live/Pending |
Remarc Vending, LLC 2023-11-29 |
OMNI 98275945 not registered Live/Pending |
IVISION TECH, Inc. 2023-11-17 |
OMNI 98274304 not registered Live/Pending |
IVISION TECH, Inc. 2023-11-16 |
OMNI 98098739 not registered Live/Pending |
GE Precision Healthcare LLC 2023-07-24 |