Galileo Extraction Tool, Capturing Rod

GUDID 00848665030891

ADVANCED ORTHOPEDIC SOLUTIONS INC

Orthopaedic implant inserter/extractor, reusable
Primary Device ID00848665030891
NIH Device Record Keyb008c7e1-d88a-4ba5-88f2-e2a6bb81e8d8
Commercial Distribution StatusIn Commercial Distribution
Brand NameGalileo Extraction Tool, Capturing Rod
Version Model Number0857-100
Company DUNS117858154
Company NameADVANCED ORTHOPEDIC SOLUTIONS INC
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 Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone3105339966
Emailregaffairs@aosortho.com
Phone3105339966
Emailregaffairs@aosortho.com
Phone3105339966
Emailregaffairs@aosortho.com
Phone3105339966
Emailregaffairs@aosortho.com
Phone3105339966
Emailregaffairs@aosortho.com
Phone3105339966
Emailregaffairs@aosortho.com
Phone3105339966
Emailregaffairs@aosortho.com
Phone3105339966
Emailregaffairs@aosortho.com
Phone3105339966
Emailregaffairs@aosortho.com
Phone3105339966
Emailregaffairs@aosortho.com
Phone3105339966
Emailregaffairs@aosortho.com
Phone3105339966
Emailregaffairs@aosortho.com
Phone3105339966
Emailregaffairs@aosortho.com
Phone3105339966
Emailregaffairs@aosortho.com
Phone3105339966
Emailregaffairs@aosortho.com
Phone3105339966
Emailregaffairs@aosortho.com
Phone3105339966
Emailregaffairs@aosortho.com
Phone3105339966
Emailregaffairs@aosortho.com
Phone3105339966
Emailregaffairs@aosortho.com
Phone3105339966
Emailregaffairs@aosortho.com
Phone3105339966
Emailregaffairs@aosortho.com
Phone3105339966
Emailregaffairs@aosortho.com
Phone3105339966
Emailregaffairs@aosortho.com
Phone3105339966
Emailregaffairs@aosortho.com
Phone3105339966
Emailregaffairs@aosortho.com
Phone3105339966
Emailregaffairs@aosortho.com
Phone3105339966
Emailregaffairs@aosortho.com
Phone3105339966
Emailregaffairs@aosortho.com
Phone3105339966
Emailregaffairs@aosortho.com
Phone3105339966
Emailregaffairs@aosortho.com
Phone3105339966
Emailregaffairs@aosortho.com
Phone3105339966
Emailregaffairs@aosortho.com
Phone3105339966
Emailregaffairs@aosortho.com
Phone3105339966
Emailregaffairs@aosortho.com
Phone3105339966
Emailregaffairs@aosortho.com
Phone3105339966
Emailregaffairs@aosortho.com
Phone3105339966
Emailregaffairs@aosortho.com
Phone3105339966
Emailregaffairs@aosortho.com
Phone3105339966
Emailregaffairs@aosortho.com
Phone3105339966
Emailregaffairs@aosortho.com
Phone3105339966
Emailregaffairs@aosortho.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100848665030891 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HSBRod, Fixation, Intramedullary And Accessories

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00848665030891]

Moist Heat or Steam Sterilization


[00848665030891]

Moist Heat or Steam Sterilization


[00848665030891]

Moist Heat or Steam Sterilization


[00848665030891]

Moist Heat or Steam Sterilization


[00848665030891]

Moist Heat or Steam Sterilization


[00848665030891]

Moist Heat or Steam Sterilization


[00848665030891]

Moist Heat or Steam Sterilization


[00848665030891]

Moist Heat or Steam Sterilization


[00848665030891]

Moist Heat or Steam Sterilization


[00848665030891]

Moist Heat or Steam Sterilization


[00848665030891]

Moist Heat or Steam Sterilization


[00848665030891]

Moist Heat or Steam Sterilization


[00848665030891]

Moist Heat or Steam Sterilization


[00848665030891]

Moist Heat or Steam Sterilization


[00848665030891]

Moist Heat or Steam Sterilization


[00848665030891]

Moist Heat or Steam Sterilization


[00848665030891]

Moist Heat or Steam Sterilization


[00848665030891]

Moist Heat or Steam Sterilization


[00848665030891]

Moist Heat or Steam Sterilization


[00848665030891]

Moist Heat or Steam Sterilization


[00848665030891]

Moist Heat or Steam Sterilization


[00848665030891]

Moist Heat or Steam Sterilization


[00848665030891]

Moist Heat or Steam Sterilization


[00848665030891]

Moist Heat or Steam Sterilization


[00848665030891]

Moist Heat or Steam Sterilization


[00848665030891]

Moist Heat or Steam Sterilization


[00848665030891]

Moist Heat or Steam Sterilization


[00848665030891]

Moist Heat or Steam Sterilization


[00848665030891]

Moist Heat or Steam Sterilization


[00848665030891]

Moist Heat or Steam Sterilization


[00848665030891]

Moist Heat or Steam Sterilization


[00848665030891]

Moist Heat or Steam Sterilization


[00848665030891]

Moist Heat or Steam Sterilization


[00848665030891]

Moist Heat or Steam Sterilization


[00848665030891]

Moist Heat or Steam Sterilization


[00848665030891]

Moist Heat or Steam Sterilization


[00848665030891]

Moist Heat or Steam Sterilization


[00848665030891]

Moist Heat or Steam Sterilization


[00848665030891]

Moist Heat or Steam Sterilization


[00848665030891]

Moist Heat or Steam Sterilization


[00848665030891]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2020-06-08
Device Publish Date2020-05-21

Devices Manufactured by ADVANCED ORTHOPEDIC SOLUTIONS INC

00848665027679 - COUNTERSINK2020-06-23
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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