AEQUALIS™ PerFORM

GUDID 03700386937675

TORNIER

Shoulder glenoid fossa prosthesis, prefabricated
Primary Device ID03700386937675
NIH Device Record Keyf5af8362-91d4-4684-811d-5133977b6ec9
Commercial Distribution StatusIn Commercial Distribution
Brand NameAEQUALIS™ PerFORM
Version Model NumberDWE532
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 Identifiers

Device Issuing AgencyDevice ID
GS103700386937675 [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™ PerFORM]

03700386937682DWE533
03700386937675DWE532
03700386937668DWE531
03700386937651DWE523
03700386937644DWE522
03700386937637DWE521
03700386937620DWE513
03700386937613DWE512
03700386937606DWE511
03700386937590DWE503
03700386937583DWE502
03700386937576DWE501
03700386937569DWE433
03700386937552DWE432
03700386937545DWE431
03700386937538DWE423
03700386937521DWE422
03700386937514DWE421
03700386937507DWE413
03700386937491DWE412
03700386937484DWE411
03700386937477DWE403
03700386937460DWE402
03700386937453DWE401
03700386937446DWE333
03700386937439DWE332
03700386937422DWE331
03700386937415DWE323
03700386937408DWE322
03700386937392DWE321
03700386937385DWE313
03700386937378DWE312
03700386937361DWE311
03700386937354DWE303
03700386937347DWE302
03700386937330DWE301

Trademark Results [AEQUALIS]

Mark Image

Registration | Serial
Company
Trademark
Application Date
AEQUALIS
AEQUALIS
87686345 5497682 Live/Registered
Nutrition DNA Pty Ltd.
2017-11-15
AEQUALIS
AEQUALIS
86159677 4927977 Live/Registered
CCP2, LLC
2014-01-07
AEQUALIS
AEQUALIS
85437537 not registered Dead/Abandoned
M&H Management Limited
2011-10-03
AEQUALIS
AEQUALIS
77730372 not registered Dead/Abandoned
M&H Management Limited
2009-05-06
AEQUALIS
AEQUALIS
74670341 2178808 Dead/Cancelled
AEQUALIS FURNITURE, L.L.C.
1995-05-05
AEQUALIS
AEQUALIS
74536909 2055775 Live/Registered
TORNIER
1994-06-13

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