AEQUALIS GLENOID

GUDID 03700386915109

TORNIER

Shoulder glenoid fossa prosthesis, prefabricated
Primary Device ID03700386915109
NIH Device Record Key2feaeca0-a52d-4a52-980b-e4af6e97e56d
Commercial Distribution StatusIn Commercial Distribution
Brand NameAEQUALIS GLENOID
Version Model NumberDWB006
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

Device Dimensions

Device Size Text, specify0

Device Identifiers

Device Issuing AgencyDevice ID
GS103700386915109 [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 GLENOID]

03700386915482DWB218
03700386915475DWB217
03700386915468DWB216
03700386915451DWB215
03700386915444DWB213
03700386915437DWB212
03700386915420DWB211
03700386915413DWB210
03700386915123DWB008
03700386915116DWB007
03700386915109DWB006
03700386915093DWB005
03700386915086DWB003
03700386915079DWB002
03700386915062DWB001

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