Universal Navigation System 130T0009

GUDID 03662663129466

Array Support

Highridge Medical, LLC

Orthopaedic fixation implant alignment tool
Primary Device ID03662663129466
NIH Device Record Key9cc567cd-9398-493e-83f8-b62260f2a445
Commercial Distribution StatusIn Commercial Distribution
Brand NameUniversal Navigation System
Version Model Number130T0009
Catalog Number130T0009
Company DUNS119260394
Company NameHighridge 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 Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)447-3625
Emailusbrocustomerservice@highridgemedical.com
Phone+1(800)447-3625
Emailusbrocustomerservice@highridgemedical.com
Phone+1(800)447-3625
Emailusbrocustomerservice@highridgemedical.com
Phone+1(800)447-3625
Emailusbrocustomerservice@highridgemedical.com
Phone+1(800)447-3625
Emailusbrocustomerservice@highridgemedical.com
Phone+1(800)447-3625
Emailusbrocustomerservice@highridgemedical.com
Phone+1(800)447-3625
Emailusbrocustomerservice@highridgemedical.com
Phone+1(800)447-3625
Emailusbrocustomerservice@highridgemedical.com
Phone+1(800)447-3625
Emailusbrocustomerservice@highridgemedical.com
Phone+1(800)447-3625
Emailusbrocustomerservice@highridgemedical.com

Device Identifiers

Device Issuing AgencyDevice ID
GS103662663129466 [Primary]

FDA Product Code

LXHOrthopedic manual surgical instrument

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[03662663129466]

Moist Heat or Steam Sterilization


[03662663129466]

Moist Heat or Steam Sterilization


[03662663129466]

Moist Heat or Steam Sterilization


[03662663129466]

Moist Heat or Steam Sterilization


[03662663129466]

Moist Heat or Steam Sterilization


[03662663129466]

Moist Heat or Steam Sterilization


[03662663129466]

Moist Heat or Steam Sterilization


[03662663129466]

Moist Heat or Steam Sterilization


[03662663129466]

Moist Heat or Steam Sterilization


[03662663129466]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-12-11
Device Publish Date2025-12-03

On-Brand Devices [Universal Navigation System]

03662663129428Standard AO Shaft
03662663129411Large AO Shaft
036626631294041/4 Square - Tri-Flat Shaft
036626631293981/4" Square - 1/4" Square Shaft
03662663218177PAT/PASIT STYLUS CASE
03662663129466Array Support
03662663129442Large & Standard AO Collet Nut
03662663129435Square & Tri-Flat Collet Nut

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.