Pedicle Screw 19-6A-PSRT

GUDID 00843511100728

Pedicle Screw Removal Tool

OMNIA MEDICAL, LLC

Surgical screwdriver, reusable
Primary Device ID00843511100728
NIH Device Record Key0f307cd5-960d-4875-9fd7-8b0346f5ceda
Commercial Distribution StatusIn Commercial Distribution
Brand NamePedicle Screw
Version Model Number19-6A-PSRT
Catalog Number19-6A-PSRT
Company DUNS079467378
Company NameOMNIA MEDICAL, LLC
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 Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone3044134851
Emailcustomerservice@omniamedical.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100843511100728 [Primary]

FDA Product Code

HXXScrewdriver

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00843511100728]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-03-10
Device Publish Date2020-03-02

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