AEQUALIS™ FLEX REVIVE™

GUDID 00846832074396

TORNIER, INC.

Coated shoulder humeral stem prosthesis
Primary Device ID00846832074396
NIH Device Record Key0a759894-8a9f-4217-883e-78b90b7f44cd
Commercial Distribution StatusIn Commercial Distribution
Brand NameAEQUALIS™ FLEX REVIVE™
Version Model NumberARS980908
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
Phone+1(888)494-7950
Emailcustomerservice@tornier.com
Phone+1(888)494-7950
Emailcustomerservice@tornier.com
Phone+1(888)494-7950
Emailcustomerservice@tornier.com
Phone+1(888)494-7950
Emailcustomerservice@tornier.com
Phone+1(888)494-7950
Emailcustomerservice@tornier.com
Phone+1(888)494-7950
Emailcustomerservice@tornier.com
Phone+1(888)494-7950
Emailcustomerservice@tornier.com
Phone+1(888)494-7950
Emailcustomerservice@tornier.com
Phone+1(888)494-7950
Emailcustomerservice@tornier.com
Phone+1(888)494-7950
Emailcustomerservice@tornier.com
Phone+1(888)494-7950
Emailcustomerservice@tornier.com
Phone+1(888)494-7950
Emailcustomerservice@tornier.com
Phone+1(888)494-7950
Emailcustomerservice@tornier.com
Phone+1(888)494-7950
Emailcustomerservice@tornier.com
Phone+1(888)494-7950
Emailcustomerservice@tornier.com
Phone+1(888)494-7950
Emailcustomerservice@tornier.com

Device Dimensions

Length130 Millimeter
Outer Diameter11 Millimeter
Length130 Millimeter
Outer Diameter11 Millimeter
Length130 Millimeter
Outer Diameter11 Millimeter
Length130 Millimeter
Outer Diameter11 Millimeter
Length130 Millimeter
Outer Diameter11 Millimeter
Length130 Millimeter
Outer Diameter11 Millimeter
Length130 Millimeter
Outer Diameter11 Millimeter
Length130 Millimeter
Outer Diameter11 Millimeter
Length130 Millimeter
Outer Diameter11 Millimeter
Length130 Millimeter
Outer Diameter11 Millimeter
Length130 Millimeter
Outer Diameter11 Millimeter
Length130 Millimeter
Outer Diameter11 Millimeter
Length130 Millimeter
Outer Diameter11 Millimeter
Length130 Millimeter
Outer Diameter11 Millimeter
Length130 Millimeter
Outer Diameter11 Millimeter
Length130 Millimeter
Outer Diameter11 Millimeter
Length130 Millimeter
Outer Diameter11 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100846832074396 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HSDPROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-07-21
Device Publish Date2020-07-13

On-Brand Devices [AEQUALIS™ FLEX REVIVE™]

00846832072279ARS655119
00846832072262ARS655118
00846832072071ARS741712
00846832072064ARS741711
00846832072057ARS741710
00846832072040ARS741709
00846832072033ARS741708
00846832072026ARS741707
00846832069644ARS741806
00846832069637ARS741805
00846832069620ARS741804
00846832069613ARS741803
00846832069606ARS741802
00846832069590ARS741801
00846832069576ARS655200
00846832069446ARS655105
00846832069439ARS655104
00846832069422ARS655103
00846832069415ARS655102
00846832069408ARS655101
00846832069392ARS342012
00846832069385ARS342011
00846832069378ARS342010
00846832069361ARS342009
00846832069354ARS342008
00846832069347ARS342007
00846832069330ARS741706
00846832069323ARS741705
00846832069316ARS741704
00846832069309ARS741703
00846832069293ARS741702
00846832069286ARS741701
00846832068869ARS742506
00846832068852ARS742505
00846832068845ARS742504
00846832068838ARS742503
00846832068821ARS742502
00846832068814ARS742501
00846832068784ARS742406
00846832068777ARS742405
00846832068760ARS742404
00846832068753ARS742403
00846832068746ARS742402
00846832068739ARS742401
00846832068722ARS742306
00846832068715ARS742305
00846832068708ARS742304
00846832068692ARS742303
00846832068685ARS742302
00846832068678ARS742301

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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