Primary Device ID | 00840606163255 |
NIH Device Record Key | 29421b13-c0d6-46e6-a7ac-ab8ffa3ad8d9 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | OmegaXP |
Version Model Number | 11402-265 |
Company DUNS | 610712213 |
Company Name | SPINAL ELEMENTS, INC. |
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 | 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 | 00840606163255 [Primary] |
LXH | Orthopedic Manual Surgical Instrument |
Steralize Prior To Use | true |
Device Is Sterile | false |
[00840606163255]
Moist Heat or Steam Sterilization
[00840606163255]
Moist Heat or Steam Sterilization
[00840606163255]
Moist Heat or Steam Sterilization
[00840606163255]
Moist Heat or Steam Sterilization
[00840606163255]
Moist Heat or Steam Sterilization
[00840606163255]
Moist Heat or Steam Sterilization
[00840606163255]
Moist Heat or Steam Sterilization
[00840606163255]
Moist Heat or Steam Sterilization
[00840606163255]
Moist Heat or Steam Sterilization
[00840606163255]
Moist Heat or Steam Sterilization
[00840606163255]
Moist Heat or Steam Sterilization
[00840606163255]
Moist Heat or Steam Sterilization
[00840606163255]
Moist Heat or Steam Sterilization
[00840606163255]
Moist Heat or Steam Sterilization
[00840606163255]
Moist Heat or Steam Sterilization
[00840606163255]
Moist Heat or Steam Sterilization
[00840606163255]
Moist Heat or Steam Sterilization
[00840606163255]
Moist Heat or Steam Sterilization
[00840606163255]
Moist Heat or Steam Sterilization
[00840606163255]
Moist Heat or Steam Sterilization
[00840606163255]
Moist Heat or Steam Sterilization
[00840606163255]
Moist Heat or Steam Sterilization
[00840606163255]
Moist Heat or Steam Sterilization
[00840606163255]
Moist Heat or Steam Sterilization
[00840606163255]
Moist Heat or Steam Sterilization
[00840606163255]
Moist Heat or Steam Sterilization
[00840606163255]
Moist Heat or Steam Sterilization
[00840606163255]
Moist Heat or Steam Sterilization
[00840606163255]
Moist Heat or Steam Sterilization
[00840606163255]
Moist Heat or Steam Sterilization
[00840606163255]
Moist Heat or Steam Sterilization
[00840606163255]
Moist Heat or Steam Sterilization
[00840606163255]
Moist Heat or Steam Sterilization
[00840606163255]
Moist Heat or Steam Sterilization
[00840606163255]
Moist Heat or Steam Sterilization
[00840606163255]
Moist Heat or Steam Sterilization
[00840606163255]
Moist Heat or Steam Sterilization
[00840606163255]
Moist Heat or Steam Sterilization
[00840606163255]
Moist Heat or Steam Sterilization
[00840606163255]
Moist Heat or Steam Sterilization
[00840606163255]
Moist Heat or Steam Sterilization
[00840606163255]
Moist Heat or Steam Sterilization
[00840606163255]
Moist Heat or Steam Sterilization
[00840606163255]
Moist Heat or Steam Sterilization
[00840606163255]
Moist Heat or Steam Sterilization
[00840606163255]
Moist Heat or Steam Sterilization
[00840606163255]
Moist Heat or Steam Sterilization
[00840606163255]
Moist Heat or Steam Sterilization
[00840606163255]
Moist Heat or Steam Sterilization
[00840606163255]
Moist Heat or Steam Sterilization
[00840606163255]
Moist Heat or Steam Sterilization
[00840606163255]
Moist Heat or Steam Sterilization
[00840606163255]
Moist Heat or Steam Sterilization
[00840606163255]
Moist Heat or Steam Sterilization
[00840606163255]
Moist Heat or Steam Sterilization
[00840606163255]
Moist Heat or Steam Sterilization
[00840606163255]
Moist Heat or Steam Sterilization
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 2 |
Public Version Date | 2021-01-22 |
Device Publish Date | 2020-11-10 |
00840916148577 | ARTICULATING RAKE W/ RATCHET |
00840916148560 | OMEGA XP™ AXIAL BREAKDOWN KNOB |
00840916148553 | LARGE OMEGA XP™ KNOB |
00840916142193 | OMEGA XP™ INSERTER ASSY |
00840606163576 | OMEGA XP™ AXIAL INSERTER - SHORT |
00840606163569 | OMEGA XP™ AXIAL INSERTER |
00840606163255 | OMEGA XP AXIAL INSERTER INNER SHAFT - SHORT |
00840606163248 | OMEGA XP AXIAL INSERTER INNER SHAFT |
00840606163224 | OMEGA XP INSERTER INNER SHAFT |
00840606163217 | OMEGA XP INSERTER - SHORT |
00840606163200 | OMEGA XP INSERTER |
00840606163194 | OMEGA XP INSERTER - SHORT |
00840606163187 | OMEGA XP INSERTER |