OMEGALIF

GUDID 00840606163606

TRAY LID

SPINAL ELEMENTS, INC.

Sterilization/disinfection container, reusable Sterilization/disinfection container, reusable Sterilization/disinfection container, reusable Sterilization/disinfection container, reusable Sterilization/disinfection container, reusable Sterilization/disinfection container, reusable Sterilization/disinfection container, reusable Sterilization/disinfection container, reusable Sterilization/disinfection container, reusable Sterilization/disinfection container, reusable Sterilization/disinfection container, reusable Sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable
Primary Device ID00840606163606
NIH Device Record Keya0f94552-f7a5-417c-9544-edc5092e644a
Commercial Distribution StatusIn Commercial Distribution
Brand NameOMEGALIF
Version Model Number11400-000-02
Company DUNS610712213
Company NameSPINAL ELEMENTS, INC.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100840606163606 [Primary]

FDA Product Code

OJHOrthopedic Tray

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00840606163606]

Moist Heat or Steam Sterilization


[00840606163606]

Moist Heat or Steam Sterilization


[00840606163606]

Moist Heat or Steam Sterilization


[00840606163606]

Moist Heat or Steam Sterilization


[00840606163606]

Moist Heat or Steam Sterilization


[00840606163606]

Moist Heat or Steam Sterilization


[00840606163606]

Moist Heat or Steam Sterilization


[00840606163606]

Moist Heat or Steam Sterilization


[00840606163606]

Moist Heat or Steam Sterilization


[00840606163606]

Moist Heat or Steam Sterilization


[00840606163606]

Moist Heat or Steam Sterilization


[00840606163606]

Moist Heat or Steam Sterilization


[00840606163606]

Moist Heat or Steam Sterilization


[00840606163606]

Moist Heat or Steam Sterilization


[00840606163606]

Moist Heat or Steam Sterilization


[00840606163606]

Moist Heat or Steam Sterilization


[00840606163606]

Moist Heat or Steam Sterilization


[00840606163606]

Moist Heat or Steam Sterilization


[00840606163606]

Moist Heat or Steam Sterilization


[00840606163606]

Moist Heat or Steam Sterilization


[00840606163606]

Moist Heat or Steam Sterilization


[00840606163606]

Moist Heat or Steam Sterilization


[00840606163606]

Moist Heat or Steam Sterilization


[00840606163606]

Moist Heat or Steam Sterilization


[00840606163606]

Moist Heat or Steam Sterilization


[00840606163606]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2021-07-08
Device Publish Date2021-01-20

On-Brand Devices [OMEGALIF]

00840606157261OmegaLIF TRAY
00840606157759OMEGALIF OFFSET INSERTER WITH IMPACTION CAP - LONG
00840606157742OMEGALIF OFFSET INSERTER WITH IMPACTION CAP - SHORT
00840606162494OMEGALIF DILATOR
00840606162487OMEGALIF 8MM DILATOR
00840606162470OMEGALIF 8MM DISC DRILL
00840606162463OMEGALIF RONGEUR
00840606162456OMEGALIF HANDLE, 1/4" SQUARE
00840606162449OMEGALIF PALM HANDLE TORQUE LIMITED 25 IN-LB
00840606162432OMEGALIF PALM HANDLE TORQUE LIMITED 20 IN-LB
00840606162425OMEGALIF PALM HANDLE TORQUE LIMITED 15 IN-LB
00840606162418OMEGALIF PALM HANDLE TORQUE LIMITED 10 IN-LB
00840606163354OMEGALIF 8MM ACCESS GUIDE
00840606163347OMEGALIF 5MM ACCESS GUIDE
00840606163330OMEGALIF DISC SHAPER INNER SHAFT
00840606163323OMEGALIF DISC SHAPER
00840606163316OMEGALIF DISC CUTTER INNER SHAFT
00840606163309OMEGALIF DISC CUTTER
00840606150439OMEGALIF INSERTER T15 TORQUE LIMITED DRIVER
00840606150446OmegaLIF INSERTER T15 TORQUE LIMITING T-HANDLE DRIVER
00840606164108LUCENT® INSERTERS & TRIALS TRAY LID
00840606164092LUCENT® INSERTERS & TRIALS TRAY BASE
00840606163965OMEGALIFTM DISC BRUSH .30 TAPERED
00840606163958OMEGALIFTM DISC BRUSH .30 STRAIGHT
00840606163743OMEGALIF TM DECORTICATOR ACCESS GUIDE
00840606163736OMEGALIF TM DECORTICATOR GRAFT TAMP
00840606163729OMEGALIF TM DECORTICATOR
00840606164078SLIM DILATOR
00840606164061DILATOR 9MM X 12MM
00840606164054DILATOR 9MM X 9MM
00840606164047PORTAL 9MM X 12MM
00840606164030PORTAL 9MM X 9MM
00840606164023OMEGALIFTM 9X12 PORTAL IMPACTOR
00840606164016OMEGALIFTM 9X9 PORTAL IMPACTOR
00840606164009OMEGALIFTM ACCESS REMOVAL ROD
00840606163972OMEGALIF SHEATH
00840606162722OMEGALIF PORTAL ARM ATTACHMENT
00840606162715OMEGALIF PORTAL T-HANDLE
00840606162708OMEGALIF PORTAL
00840606162692OMEGALIF ARTICULATING RAKE, CURETTE
00840606162685OMEGALIF ARTICULATING RAKE, SCRAPER
00840606167192OMEGALIF DELIVERY GUIDE
00840606163637TRAY TOP INSERT
00840606163620TRAY MIDDLE INSERT
00840606163613TRAY BOTTOM INSERT
00840606163606TRAY LID
00840606163590TRAY BASE
00840606163583TRAY ASSEMBLY
00840606170062OmegaLIF® INSERTER SLEEVE
00840606170055OmegaLIF® INSERTER INNER SHAFT

Trademark Results [OMEGALIF]

Mark Image

Registration | Serial
Company
Trademark
Application Date
OMEGALIF
OMEGALIF
88329987 not registered Live/Pending
Amendia, Inc.
2019-03-07
OMEGALIF
OMEGALIF
88325016 not registered Live/Pending
Amendia, Inc.
2019-03-04

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