AEQUALIS™ PerFORM+ Reversed

GUDID 00846832062034

TORNIER, INC.

Reverse shoulder prosthesis base plate
Primary Device ID00846832062034
NIH Device Record Key02fd06cc-ca3b-4679-9de4-1522f4c09b8a
Commercial Distribution StatusIn Commercial Distribution
Brand NameAEQUALIS™ PerFORM+ Reversed
Version Model NumberDWJ514
Company DUNS968990812
Company NameTORNIER, 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 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+1(888)494-7950
Emailcustomerservice@tornier.com

Device Dimensions

Outer Diameter29 Millimeter
Outer Diameter29 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100846832062034 [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 Number3
Public Version Date2018-07-06
Device Publish Date2016-11-21

On-Brand Devices [AEQUALIS™ PerFORM+ Reversed]

00846832062065DWJ505
00846832062058DWJ515
00846832062041DWJ504
00846832062034DWJ514
00846832062027DWJ503
00846832062010DWJ502
00846832062003DWJ513
00846832061990DWJ512

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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