Patriot SI

GUDID M9433500070000

Single Use Instrument Kit

Spinal Simplicity, LLC

Orthopaedic surgical procedure kit, non-medicated, single-use
Primary Device IDM9433500070000
NIH Device Record Keydc98a284-5db2-459f-9be1-69ec2917e36b
Commercial Distribution StatusIn Commercial Distribution
Brand NamePatriot SI
Version Model Number35-0007-000
Company DUNS963359513
Company NameSpinal Simplicity, 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 Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCM9433500070000 [Primary]

FDA Product Code

LXHOrthopedic Manual Surgical Instrument

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-06-23
Device Publish Date2025-06-13

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M9432001860000Guidewire, Blunt
M9432001850000Insertion Instrument
M9430018700000Guidewire, Trocar
M9431001750000Posterior SI Joint Fusion Implant
M9432001990000Luer Insertion Instrument
M9433500070000Single Use Instrument Kit

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