Affiniti™ EH²

GUDID 00846832002221

TORNIER, INC.

Coated shoulder humeral stem prosthesis
Primary Device ID00846832002221
NIH Device Record Key6b86f8e6-ae33-4902-a5e1-51113251925e
Commercial Distribution StatusIn Commercial Distribution
Brand NameAffiniti™ EH²
Version Model Number0020082
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 Batchtrue
Serial Numberfalse
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
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

Outer Diameter52 Millimeter
Outer Diameter52 Millimeter
Device Size Text, specify0
Outer Diameter52 Millimeter
Device Size Text, specify0
Outer Diameter52 Millimeter
Device Size Text, specify0
Outer Diameter52 Millimeter
Device Size Text, specify0
Outer Diameter52 Millimeter
Device Size Text, specify0
Outer Diameter52 Millimeter
Device Size Text, specify0
Outer Diameter52 Millimeter
Device Size Text, specify0
Outer Diameter52 Millimeter
Device Size Text, specify0
Outer Diameter52 Millimeter
Device Size Text, specify0
Outer Diameter52 Millimeter
Device Size Text, specify0
Outer Diameter52 Millimeter
Device Size Text, specify0
Outer Diameter52 Millimeter
Device Size Text, specify0
Outer Diameter52 Millimeter
Device Size Text, specify0
Outer Diameter52 Millimeter
Device Size Text, specify0
Outer Diameter52 Millimeter
Device Size Text, specify0
Outer Diameter52 Millimeter
Device Size Text, specify0
Outer Diameter52 Millimeter
Device Size Text, specify0
Outer Diameter52 Millimeter
Device Size Text, specify0
Outer Diameter52 Millimeter
Device Size Text, specify0
Outer Diameter52 Millimeter
Device Size Text, specify0
Outer Diameter52 Millimeter
Device Size Text, specify0
Outer Diameter52 Millimeter
Device Size Text, specify0
Outer Diameter52 Millimeter
Device Size Text, specify0
Outer Diameter52 Millimeter
Device Size Text, specify0
Outer Diameter52 Millimeter
Device Size Text, specify0
Outer Diameter52 Millimeter
Device Size Text, specify0
Outer Diameter52 Millimeter
Device Size Text, specify0
Outer Diameter52 Millimeter
Device Size Text, specify0
Outer Diameter52 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100846832002221 [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 StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2015-10-16

On-Brand Devices [Affiniti™ EH²]

008468320022520020085
008468320022450020084
008468320022380020083
008468320022210020082
008468320022140020081
008468320022070020080
008468320021910020079
008468320021840020078

Trademark Results [Affiniti]

Mark Image

Registration | Serial
Company
Trademark
Application Date
AFFINITI
AFFINITI
97477382 not registered Live/Pending
SuperLayer Labs Management, LLC
2022-06-27
AFFINITI
AFFINITI
97044570 not registered Live/Pending
Halyard MD Opco, LLC
2021-09-24
AFFINITI
AFFINITI
85514563 not registered Dead/Abandoned
KATZ, Steven
2012-01-11
AFFINITI
AFFINITI
85514563 not registered Dead/Abandoned
KATZ, Cecile
2012-01-11
AFFINITI
AFFINITI
81016986 1016986 Dead/Cancelled
Wilwood, Inc.
0000-00-00
AFFINITI
AFFINITI
79143766 4590914 Live/Registered
Koninklijke Philips nv
2014-01-22
AFFINITI
AFFINITI
77873733 3938734 Live/Registered
Tornier, Inc.
2009-11-16
AFFINITI
AFFINITI
77813762 not registered Dead/Abandoned
Terrazzo & Marble Supply Co. of IL
2009-08-27
AFFINITI
AFFINITI
77593592 not registered Dead/Abandoned
DATALOGIX, INC.
2008-10-15
AFFINITI
AFFINITI
77100548 not registered Dead/Abandoned
Farberware Licensing Company, LLC
2007-02-06
AFFINITI
AFFINITI
76154175 not registered Dead/Abandoned
Affiniti, Inc.
2000-10-26
AFFINITI
AFFINITI
74597990 1928253 Dead/Cancelled
CIGNA Corporation
1994-11-14

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