OmegaLIF
GUDID 00840916155667
CORING TOOL 10mm
SPINAL ELEMENTS
Bone trephine| Primary Device ID | 00840916155667 |
| NIH Device Record Key | a1472cd3-9ff8-47d7-818a-319ed59d1240 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | OmegaLIF |
| Version Model Number | 72-09-010 |
| Company DUNS | 004022104 |
| Company Name | SPINAL ELEMENTS |
| 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 | true |
| 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 Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00840916155667 [Primary] |
FDA Product Code
| LXH | Orthopedic Manual Surgical Instrument |
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00840916155667]
Moist Heat or Steam Sterilization
[00840916155667]
Moist Heat or Steam Sterilization
[00840916155667]
Moist Heat or Steam Sterilization
[00840916155667]
Moist Heat or Steam Sterilization
[00840916155667]
Moist Heat or Steam Sterilization
[00840916155667]
Moist Heat or Steam Sterilization
[00840916155667]
Moist Heat or Steam Sterilization
[00840916155667]
Moist Heat or Steam Sterilization
[00840916155667]
Moist Heat or Steam Sterilization
[00840916155667]
Moist Heat or Steam Sterilization
[00840916155667]
Moist Heat or Steam Sterilization
[00840916155667]
Moist Heat or Steam Sterilization
[00840916155667]
Moist Heat or Steam Sterilization
[00840916155667]
Moist Heat or Steam Sterilization
[00840916155667]
Moist Heat or Steam Sterilization
[00840916155667]
Moist Heat or Steam Sterilization
[00840916155667]
Moist Heat or Steam Sterilization
[00840916155667]
Moist Heat or Steam Sterilization
[00840916155667]
Moist Heat or Steam Sterilization
[00840916155667]
Moist Heat or Steam Sterilization
[00840916155667]
Moist Heat or Steam Sterilization
[00840916155667]
Moist Heat or Steam Sterilization
[00840916155667]
Moist Heat or Steam Sterilization
[00840916155667]
Moist Heat or Steam Sterilization
[00840916155667]
Moist Heat or Steam Sterilization
[00840916155667]
Moist Heat or Steam Sterilization
[00840916155667]
Moist Heat or Steam Sterilization
[00840916155667]
Moist Heat or Steam Sterilization
[00840916155667]
Moist Heat or Steam Sterilization
[00840916155667]
Moist Heat or Steam Sterilization
[00840916155667]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2019-10-18 |
| Device Publish Date | 2019-09-06 |
On-Brand Devices [OmegaLIF]
| 00840916155674 | CORING TOOL 12mm |
| 00840916155667 | CORING TOOL 10mm |
| 00840916155650 | CORING TOOL 8mm |
| 00840916124601 | OmegaLIF 9mm Wide x 28mm Long x 8mm Collapsed Height x Parallel (8-11) |
| 00840916124717 | OmegaLIF 11mm Wide x 28mm Long x 13mm Collapsed Height x 11 degree Single Lordosis (13-16) |
| 00840916124700 | OmegaLIF 11mm Wide x 28mm Long x 11mm Collapsed Height x 11 degree Single Lordosis (11-14) |
| 00840916124694 | OmegaLIF 9mm Wide x 28mm Long x 13mm Collapsed Height x 11 degree Single Lordosis (13-16) |
| 00840916124687 | OmegaLIF 9mm Wide x 28mm Long x 12mm Collapsed Height x 11 degree Single Lordosis (12-15) |
| 00840916124670 | OmegaLIF 11mm Wide x 28mm Long x 11mm Collapsed Height x 4 degree Single Lordosis (11-14) |
| 00840916124663 | OmegaLIF 9mm Wide x 28mm Long x 11mm Collapsed Height x 4 degree Single Lordosis (11-14) |
| 00840916124656 | OmegaLIF 11mm Wide x 28mm Long x 9mm Collapsed Height x 4 degree Single Lordosis (9-12) |
| 00840916124649 | OmegaLIF 9mm Wide x 28mm Long x 9mm Collapsed Height x 4 degree Single Lordosis (9-12) |
| 00840916124632 | OmegaLIF 11mm Wide x 28mm Long x 12mm Collapsed Height x 11 degree Single Lordosis (12-15) |
| 00840916124625 | OmegaLIF 11mm Wide x 28mm Long x 8mm Collapsed Height x Parallel (8-11) |
| 00840916124618 | OmegaLIF 9mm Wide x 28mm Long x 10mm Collapsed Height x Parallel (10-13) |
| 00840916155582 | OmegaLIF offset inserter shaft – Long |
| 00840916155575 | OmegaLIF offset inserter shaft – Short |
| 00840916142278 | OmegaLIF IRRIGATION DILATOR |
| 00840916142261 | OmegaLIF AXIAL BREAKDOWN KNOB |
| 00840916142254 | OmegaLIF Instrument Tray Case |
| 00840916142247 | OmegaLIF T-HANDLE TRIAL |
| 00840916142230 | OmegaLIF T-HANDLE INSERTER ASSY |
| 00840916142223 | OmegaLIF REMOVAL TOOL |
| 00840916142216 | Omega LLIF Expanding Trial |
| 00840916142209 | Omega LLIF Expanding Trial |
| 00840916133269 | OMEGA XP™ 9MM X 34MM X 11MM 8° C |
| 00840916133252 | OMEGA XP™ 9MM X 34MM X 11MM 3° C |
| 00840916133245 | OMEGA XP™ 9MM X 34MM X 10MM 3° C |
| 00840916133238 | OMEGA XP™ 9MM X 34MM X 9MM 3° C |
| 00840916133221 | OMEGA XP™ 9MM X 34MM X 8MM 0° |
| 00840916162160 | TORQUE PALM AO HANDLE |
| 00840916148546 | TORQUE PALM AO INTERNAL ADAPTER |
Trademark Results [OmegaLIF]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 OMEGALIF 88329987 not registered Live/Pending |
Amendia, Inc. 2019-03-07 |
 OMEGALIF 88325016 not registered Live/Pending |
Amendia, Inc. 2019-03-04 |
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