CAPTURING ROD, GALILEO™ LAG SCREW

GUDID 00848665021455

ADVANCED ORTHOPEDIC SOLUTIONS INC

Orthopaedic instrument surgical connector
Primary Device ID00848665021455
NIH Device Record Key98364ed9-cc5a-4270-b6a1-5cd832d50073
Commercial Distribution StatusIn Commercial Distribution
Brand NameCAPTURING ROD, GALILEO™ LAG SCREW
Version Model Number0455-100
Company DUNS117858154
Company NameADVANCED ORTHOPEDIC SOLUTIONS INC
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 Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone(310) 533-9966
Emailregaffairs@aosortho.com
Phone(310) 533-9966
Emailregaffairs@aosortho.com
Phone(310) 533-9966
Emailregaffairs@aosortho.com
Phone(310) 533-9966
Emailregaffairs@aosortho.com
Phone(310) 533-9966
Emailregaffairs@aosortho.com
Phone(310) 533-9966
Emailregaffairs@aosortho.com
Phone(310) 533-9966
Emailregaffairs@aosortho.com
Phone(310) 533-9966
Emailregaffairs@aosortho.com
Phone(310) 533-9966
Emailregaffairs@aosortho.com
Phone(310) 533-9966
Emailregaffairs@aosortho.com
Phone(310) 533-9966
Emailregaffairs@aosortho.com
Phone(310) 533-9966
Emailregaffairs@aosortho.com
Phone(310) 533-9966
Emailregaffairs@aosortho.com
Phone(310) 533-9966
Emailregaffairs@aosortho.com
Phone(310) 533-9966
Emailregaffairs@aosortho.com
Phone(310) 533-9966
Emailregaffairs@aosortho.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100848665021455 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HSBRod, Fixation, Intramedullary And Accessories
LXHOrthopedic Manual Surgical Instrument

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00848665021455]

Moist Heat or Steam Sterilization


[00848665021455]

Moist Heat or Steam Sterilization


[00848665021455]

Moist Heat or Steam Sterilization


[00848665021455]

Moist Heat or Steam Sterilization


[00848665021455]

Moist Heat or Steam Sterilization


[00848665021455]

Moist Heat or Steam Sterilization


[00848665021455]

Moist Heat or Steam Sterilization


[00848665021455]

Moist Heat or Steam Sterilization


[00848665021455]

Moist Heat or Steam Sterilization


[00848665021455]

Moist Heat or Steam Sterilization


[00848665021455]

Moist Heat or Steam Sterilization


[00848665021455]

Moist Heat or Steam Sterilization


[00848665021455]

Moist Heat or Steam Sterilization


[00848665021455]

Moist Heat or Steam Sterilization


[00848665021455]

Moist Heat or Steam Sterilization


[00848665021455]

Moist Heat or Steam Sterilization


[00848665021455]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-12-07
Device Publish Date2016-02-23

Devices Manufactured by ADVANCED ORTHOPEDIC SOLUTIONS INC

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00848665000658 - AOS Drill, AO Style, 2.9mm x 100mm2020-06-08
00848665001235 - AOS CANCELLOUS TAP 3.5mm2020-06-08
00848665027624 - SUPRAPATELLAR TIBIAL ENTRY SHEATH2020-06-08
00848665028041 - T10 Screwdriver, Short2020-06-08
00848665028096 - 3.5mm Calibrated Drill2020-06-08
00848665028119 - AOS 2.6mm Solid Reamer2020-06-08
00848665028782 - T10 Screwdriver, Solid2020-06-08

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