AEQUALIS REVERSED II

GUDID 03700386935879

TORNIER

Shoulder glenoid fossa prosthesis, prefabricated
Primary Device ID03700386935879
NIH Device Record Key699c9441-7417-44c6-ba66-f02c3f020e32
Commercial Distribution StatusIn Commercial Distribution
Brand NameAEQUALIS REVERSED II
Version Model NumberDWD185
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
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

Outer Diameter42 Millimeter
Outer Diameter42 Millimeter
Device Size Text, specify0
Outer Diameter42 Millimeter
Device Size Text, specify0
Outer Diameter42 Millimeter
Device Size Text, specify0
Outer Diameter42 Millimeter
Device Size Text, specify0
Outer Diameter42 Millimeter
Device Size Text, specify0
Outer Diameter42 Millimeter
Device Size Text, specify0
Outer Diameter42 Millimeter
Device Size Text, specify0
Outer Diameter42 Millimeter
Device Size Text, specify0
Outer Diameter42 Millimeter
Device Size Text, specify0
Outer Diameter42 Millimeter
Device Size Text, specify0
Outer Diameter42 Millimeter
Device Size Text, specify0
Outer Diameter42 Millimeter
Device Size Text, specify0
Outer Diameter42 Millimeter
Device Size Text, specify0
Outer Diameter42 Millimeter
Device Size Text, specify0
Outer Diameter42 Millimeter
Device Size Text, specify0
Outer Diameter42 Millimeter
Device Size Text, specify0
Outer Diameter42 Millimeter
Device Size Text, specify0
Outer Diameter42 Millimeter
Device Size Text, specify0
Outer Diameter42 Millimeter
Device Size Text, specify0
Outer Diameter42 Millimeter
Device Size Text, specify0
Outer Diameter42 Millimeter
Device Size Text, specify0
Outer Diameter42 Millimeter
Device Size Text, specify0
Outer Diameter42 Millimeter
Device Size Text, specify0
Outer Diameter42 Millimeter
Device Size Text, specify0
Outer Diameter42 Millimeter
Device Size Text, specify0

Device Identifiers

Device Issuing AgencyDevice ID
GS103700386935879 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KWSPROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-12-23
Device Publish Date2015-10-16

On-Brand Devices [AEQUALIS REVERSED II]

03700386952890DWE892
03700386952883DWE891
03700386952876DWE890
03700386952869DWE882
03700386952852DWE881
03700386952845DWE880
03700386952838DWE872
03700386952821DWE871
03700386952814DWE870
03700386952807DWE862
03700386952791DWE861
03700386952784DWE860
03700386935930DWD195
03700386935923DWD194
03700386935916DWD193
03700386935909DWD192
03700386935893DWD191
03700386935886DWD190
03700386935879DWD185
03700386935862DWD184
03700386935855DWD183
03700386935848DWD182
03700386935831DWD181
03700386935824DWD180
03700386952753DWE840
03700386952746DWE835
03700386952722DWE825
03700386952715DWE820
03700386952678DWE735
03700386952647DWE720
03700386955273DWH919
03700386955266DWH918
03700386955259DWH917
03700386955242DWH916
03700386955235DWH915
03700386955228DWH914
03700386955211DWH913
03700386955204DWH912
03700386955198DWH911
03700386955174DWH909
03700386955150DWH908
03700386955136DWH907
03700386955112DWH906
03700386955099DWH905
03700386955075DWH904
03700386955051DWH903
03700386955037DWH902
03700386955013DWH901
03700386952777DWE850
03700386952760DWE845

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