AEQUALIS HUMERAL PLATE

GUDID 03700386928819

TORNIER

Orthopaedic bone wire
Primary Device ID03700386928819
NIH Device Record Key4c7e521d-b422-4fa3-827a-b535554d7fbf
Commercial Distribution Discontinuation2018-10-01
Commercial Distribution StatusNot in Commercial Distribution
Brand NameAEQUALIS HUMERAL PLATE
Version Model NumberDWD010
Company DUNS260324876
Company NameTORNIER
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 Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+330476613500
Emailorder@tornier.com
Phone+330476613500
Emailorder@tornier.com
Phone+330476613500
Emailorder@tornier.com
Phone+330476613500
Emailorder@tornier.com
Phone+330476613500
Emailorder@tornier.com
Phone+330476613500
Emailorder@tornier.com
Phone+330476613500
Emailorder@tornier.com
Phone+330476613500
Emailorder@tornier.com
Phone+330476613500
Emailorder@tornier.com
Phone+330476613500
Emailorder@tornier.com
Phone+330476613500
Emailorder@tornier.com
Phone+330476613500
Emailorder@tornier.com
Phone+330476613500
Emailorder@tornier.com
Phone+330476613500
Emailorder@tornier.com
Phone+330476613500
Emailorder@tornier.com
Phone+330476613500
Emailorder@tornier.com
Phone+330476613500
Emailorder@tornier.com

Device Dimensions

Length300 Millimeter
Outer Diameter1 Millimeter
Length300 Millimeter
Outer Diameter1 Millimeter
Length300 Millimeter
Outer Diameter1 Millimeter
Length300 Millimeter
Outer Diameter1 Millimeter
Length300 Millimeter
Outer Diameter1 Millimeter
Length300 Millimeter
Outer Diameter1 Millimeter
Length300 Millimeter
Outer Diameter1 Millimeter
Length300 Millimeter
Outer Diameter1 Millimeter
Length300 Millimeter
Outer Diameter1 Millimeter
Length300 Millimeter
Outer Diameter1 Millimeter
Length300 Millimeter
Outer Diameter1 Millimeter
Length300 Millimeter
Outer Diameter1 Millimeter
Length300 Millimeter
Outer Diameter1 Millimeter
Length300 Millimeter
Outer Diameter1 Millimeter
Length300 Millimeter
Outer Diameter1 Millimeter
Length300 Millimeter
Outer Diameter1 Millimeter
Length300 Millimeter
Outer Diameter1 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS103700386928819 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KTTAPPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2020-06-11
Device Publish Date2015-10-16

Devices Manufactured by TORNIER

03700434015058 - Blueprint2024-10-07 Win
03700434015065 - Blueprint2024-10-07 Mac
03700434023824 - Blueprint Mixed Reality2024-08-13 HOLOBLUEPRINT™
03700434023176 - AEQUALIS REVERSED FRACTURE2024-07-04 Humeral Insert
03700434023183 - AEQUALIS REVERSED FRACTURE2024-07-04 Humeral Insert
03700434023190 - AEQUALIS REVERSED FRACTURE2024-07-04 Humeral Insert
03700434023695 - Shoulder iD2024-05-31 BLUEPRINT Primary Reversed Glenoid Guide
03700434023701 - Shoulder iD2024-05-31 BLUEPRINT Primary Reversed Glenoid Guide

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