Omni

GUDID 00840916111489

5.0mm x 45mm Lo-Top Talon Screw

SPINAL ELEMENTS

Bone-screw internal spinal fixation system, non-sterile
Primary Device ID00840916111489
NIH Device Record Keydd18cb82-260e-4f50-ab0c-5f724e35dcf2
Commercial Distribution StatusIn Commercial Distribution
Brand NameOmni
Version Model NumberST05045
Company DUNS004022104
Company NameSPINAL ELEMENTS
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
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
GS100840916111489 [Primary]

FDA Product Code

MNIOrthosis, Spinal Pedicle Fixation

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00840916111489]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2020-03-25
Device Publish Date2017-07-10

On-Brand Devices [Omni]

008409161114895.0mm x 45mm Lo-Top Talon Screw
008409161114725.0mm x 40mm Lo-Top Talon Screw
008409161099507.0mm x 45mm Reduction Tab Screw

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