Aequalis™ PerFORM+

GUDID 00846832066445

TORNIER, INC.

Shoulder glenoid fossa prosthesis, prefabricated
Primary Device ID00846832066445
NIH Device Record Key218f344d-371b-4fab-b2f0-246e16d309ae
Commercial Distribution StatusIn Commercial Distribution
Brand NameAequalis™ PerFORM+
Version Model NumberDWK403RA15S
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

Angle15 degree
Angle15 degree

Device Identifiers

Device Issuing AgencyDevice ID
GS100846832066445 [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 Date2016-06-14

On-Brand Devices [Aequalis™ PerFORM+]

00846832067138DWK403LA15S
00846832066643DWK406RA35S
00846832066636DWK406RA25S
00846832066629DWK406RA15S
00846832066612DWK406LA35S
00846832066605DWK406LA25S
00846832066599DWK406LA15S
00846832066582DWK405RA35S
00846832066575DWK405RA25S
00846832066568DWK405RA15S
00846832066551DWK405LA35S
00846832066544DWK405LA25S
00846832066537DWK405LA15S
00846832066520DWK404RA35S
00846832066513DWK404RA25S
00846832066506DWK404RA15S
00846832066490DWK404LA35S
00846832066483DWK404LA25S
00846832066476DWK404LA15S
00846832066469DWK403RA35S
00846832066452DWK403RA25S
00846832066445DWK403RA15S
00846832066438DWK403LA35S
00846832066421DWK403LA25S
00846832062140DWK403RA35
00846832062133DWK403RA25
00846832062126DWK403RA15
00846832062119DWK403LA35
00846832062102DWK403LA25
00846832062096DWK403LA15
00846832061860DWK506RA35
00846832061853DWK506RA25
00846832061846DWK506RA15
00846832061839DWK506LA35
00846832061822DWK506LA25
00846832061815DWK506LA15
00846832061808DWK505RA35
00846832061792DWK505RA25
00846832061785DWK505RA15
00846832061778DWK505LA35
00846832061761DWK505LA25
00846832061754DWK505LA15
00846832061747DWK504RA35
00846832061730DWK504RA25
00846832061723DWK504RA15
00846832061716DWK504LA35
00846832061709DWK504LA25
00846832061693DWK504LA15
00846832061686DWK503RA35
00846832061679DWK503RA25

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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