OMEGALIF
GUDID 00840916162160
TORQUE PALM AO HANDLE
SPINAL ELEMENTS
Orthopaedic prosthesis implantation instrument, reusable Orthopaedic prosthesis implantation instrument, reusable Orthopaedic prosthesis implantation instrument, reusable Orthopaedic prosthesis implantation instrument, reusable Orthopaedic prosthesis implantation instrument, reusable Orthopaedic prosthesis implantation instrument, reusable Orthopaedic prosthesis implantation instrument, reusable Orthopaedic prosthesis implantation instrument, reusable Orthopaedic prosthesis implantation instrument, reusable Orthopaedic prosthesis implantation instrument, reusable Orthopaedic prosthesis implantation instrument, reusable Orthopaedic prosthesis implantation instrument, reusable Orthopaedic prosthesis implantation instrument, reusable Orthopaedic prosthesis implantation instrument, reusable Orthopaedic prosthesis implantation instrument, reusable Orthopaedic prosthesis implantation instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable| Primary Device ID | 00840916162160 |
| NIH Device Record Key | c0211667-c092-485c-bd83-3ba18d56a494 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | OMEGALIF |
| Version Model Number | TD-301416-15-HC |
| 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 | 00840916162160 [Primary] |
FDA Product Code
| LXH | Orthopedic Manual Surgical Instrument |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00840916162160]
Moist Heat or Steam Sterilization
[00840916162160]
Moist Heat or Steam Sterilization
[00840916162160]
Moist Heat or Steam Sterilization
[00840916162160]
Moist Heat or Steam Sterilization
[00840916162160]
Moist Heat or Steam Sterilization
[00840916162160]
Moist Heat or Steam Sterilization
[00840916162160]
Moist Heat or Steam Sterilization
[00840916162160]
Moist Heat or Steam Sterilization
[00840916162160]
Moist Heat or Steam Sterilization
[00840916162160]
Moist Heat or Steam Sterilization
[00840916162160]
Moist Heat or Steam Sterilization
[00840916162160]
Moist Heat or Steam Sterilization
[00840916162160]
Moist Heat or Steam Sterilization
[00840916162160]
Moist Heat or Steam Sterilization
[00840916162160]
Moist Heat or Steam Sterilization
[00840916162160]
Moist Heat or Steam Sterilization
[00840916162160]
Moist Heat or Steam Sterilization
[00840916162160]
Moist Heat or Steam Sterilization
[00840916162160]
Moist Heat or Steam Sterilization
[00840916162160]
Moist Heat or Steam Sterilization
[00840916162160]
Moist Heat or Steam Sterilization
[00840916162160]
Moist Heat or Steam Sterilization
[00840916162160]
Moist Heat or Steam Sterilization
[00840916162160]
Moist Heat or Steam Sterilization
[00840916162160]
Moist Heat or Steam Sterilization
[00840916162160]
Moist Heat or Steam Sterilization
[00840916162160]
Moist Heat or Steam Sterilization
[00840916162160]
Moist Heat or Steam Sterilization
[00840916162160]
Moist Heat or Steam Sterilization
[00840916162160]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-03-04 |
| Device Publish Date | 2022-02-24 |
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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