GUDID 00840916111472

5.0mm x 40mm Lo-Top Talon Screw


Bone-screw internal spinal fixation system, non-sterile
Primary Device ID00840916111472
NIH Device Record Key8df12fcf-490d-4384-88f0-574eec24d67c
Commercial Distribution StatusIn Commercial Distribution
Brand NameOmni
Version Model NumberST05040
Company DUNS004022104
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
GS100840916111472 [Primary]

FDA Product Code

MNIOrthosis, Spinal Pedicle Fixation


Steralize Prior To Usetrue
Device Is Sterilefalse


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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