Primary Device ID | 00840606163613 |
NIH Device Record Key | f766cd96-960f-4f03-8baf-f6d70ba01cc5 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | OMEGALIF |
Version Model Number | 11400-000-03 |
Company DUNS | 610712213 |
Company Name | SPINAL ELEMENTS, INC. |
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 Issuing Agency | Device ID |
---|---|
GS1 | 00840606163613 [Primary] |
OJH | Orthopedic Tray |
Steralize Prior To Use | true |
Device Is Sterile | false |
[00840606163613]
Moist Heat or Steam Sterilization
[00840606163613]
Moist Heat or Steam Sterilization
[00840606163613]
Moist Heat or Steam Sterilization
[00840606163613]
Moist Heat or Steam Sterilization
[00840606163613]
Moist Heat or Steam Sterilization
[00840606163613]
Moist Heat or Steam Sterilization
[00840606163613]
Moist Heat or Steam Sterilization
[00840606163613]
Moist Heat or Steam Sterilization
[00840606163613]
Moist Heat or Steam Sterilization
[00840606163613]
Moist Heat or Steam Sterilization
[00840606163613]
Moist Heat or Steam Sterilization
[00840606163613]
Moist Heat or Steam Sterilization
[00840606163613]
Moist Heat or Steam Sterilization
[00840606163613]
Moist Heat or Steam Sterilization
[00840606163613]
Moist Heat or Steam Sterilization
[00840606163613]
Moist Heat or Steam Sterilization
[00840606163613]
Moist Heat or Steam Sterilization
[00840606163613]
Moist Heat or Steam Sterilization
[00840606163613]
Moist Heat or Steam Sterilization
[00840606163613]
Moist Heat or Steam Sterilization
[00840606163613]
Moist Heat or Steam Sterilization
[00840606163613]
Moist Heat or Steam Sterilization
[00840606163613]
Moist Heat or Steam Sterilization
[00840606163613]
Moist Heat or Steam Sterilization
[00840606163613]
Moist Heat or Steam Sterilization
[00840606163613]
Moist Heat or Steam Sterilization
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 2 |
Public Version Date | 2021-07-08 |
Device Publish Date | 2021-01-20 |
00840606157261 | OmegaLIF TRAY |
00840606157759 | OMEGALIF OFFSET INSERTER WITH IMPACTION CAP - LONG |
00840606157742 | OMEGALIF OFFSET INSERTER WITH IMPACTION CAP - SHORT |
00840606162494 | OMEGALIF DILATOR |
00840606162487 | OMEGALIF 8MM DILATOR |
00840606162470 | OMEGALIF 8MM DISC DRILL |
00840606162463 | OMEGALIF RONGEUR |
00840606162456 | OMEGALIF HANDLE, 1/4" SQUARE |
00840606162449 | OMEGALIF PALM HANDLE TORQUE LIMITED 25 IN-LB |
00840606162432 | OMEGALIF PALM HANDLE TORQUE LIMITED 20 IN-LB |
00840606162425 | OMEGALIF PALM HANDLE TORQUE LIMITED 15 IN-LB |
00840606162418 | OMEGALIF PALM HANDLE TORQUE LIMITED 10 IN-LB |
00840606163354 | OMEGALIF 8MM ACCESS GUIDE |
00840606163347 | OMEGALIF 5MM ACCESS GUIDE |
00840606163330 | OMEGALIF DISC SHAPER INNER SHAFT |
00840606163323 | OMEGALIF DISC SHAPER |
00840606163316 | OMEGALIF DISC CUTTER INNER SHAFT |
00840606163309 | OMEGALIF DISC CUTTER |
00840606150439 | OMEGALIF INSERTER T15 TORQUE LIMITED DRIVER |
00840606150446 | OmegaLIF INSERTER T15 TORQUE LIMITING T-HANDLE DRIVER |
00840606164108 | LUCENT® INSERTERS & TRIALS TRAY LID |
00840606164092 | LUCENT® INSERTERS & TRIALS TRAY BASE |
00840606163965 | OMEGALIFTM DISC BRUSH .30 TAPERED |
00840606163958 | OMEGALIFTM DISC BRUSH .30 STRAIGHT |
00840606163743 | OMEGALIF TM DECORTICATOR ACCESS GUIDE |
00840606163736 | OMEGALIF TM DECORTICATOR GRAFT TAMP |
00840606163729 | OMEGALIF TM DECORTICATOR |
00840606164078 | SLIM DILATOR |
00840606164061 | DILATOR 9MM X 12MM |
00840606164054 | DILATOR 9MM X 9MM |
00840606164047 | PORTAL 9MM X 12MM |
00840606164030 | PORTAL 9MM X 9MM |
00840606164023 | OMEGALIFTM 9X12 PORTAL IMPACTOR |
00840606164016 | OMEGALIFTM 9X9 PORTAL IMPACTOR |
00840606164009 | OMEGALIFTM ACCESS REMOVAL ROD |
00840606163972 | OMEGALIF SHEATH |
00840606162722 | OMEGALIF PORTAL ARM ATTACHMENT |
00840606162715 | OMEGALIF PORTAL T-HANDLE |
00840606162708 | OMEGALIF PORTAL |
00840606162692 | OMEGALIF ARTICULATING RAKE, CURETTE |
00840606162685 | OMEGALIF ARTICULATING RAKE, SCRAPER |
00840606167192 | OMEGALIF DELIVERY GUIDE |
00840606163637 | TRAY TOP INSERT |
00840606163620 | TRAY MIDDLE INSERT |
00840606163613 | TRAY BOTTOM INSERT |
00840606163606 | TRAY LID |
00840606163590 | TRAY BASE |
00840606163583 | TRAY ASSEMBLY |
00840606170062 | OmegaLIF® INSERTER SLEEVE |
00840606170055 | OmegaLIF® INSERTER INNER SHAFT |
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 |