LATITUDE EV™ 0030721

GUDID 00846832074815

TORNIER, INC.

Coated elbow humerus prosthesis Coated elbow humerus prosthesis Coated elbow humerus prosthesis Coated elbow humerus prosthesis Coated elbow humerus prosthesis Coated elbow humerus prosthesis Coated elbow humerus prosthesis Coated elbow humerus prosthesis Coated elbow humerus prosthesis Coated elbow humerus prosthesis Coated elbow humerus prosthesis Coated elbow humerus prosthesis Coated elbow humerus prosthesis Coated elbow humerus prosthesis Coated elbow humerus prosthesis Coated elbow humerus prosthesis
Primary Device ID00846832074815
NIH Device Record Key3b69e539-aeef-4dff-9274-9bd8d929a40c
Commercial Distribution StatusIn Commercial Distribution
Brand NameLATITUDE EV™
Version Model Number0030721
Catalog Number0030721
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 Datetrue
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

Device Dimensions

Device Size Text, specify0
Length83 Millimeter
Device Size Text, specify0
Length83 Millimeter
Device Size Text, specify0
Length83 Millimeter
Device Size Text, specify0
Length83 Millimeter
Device Size Text, specify0
Length83 Millimeter
Device Size Text, specify0
Length83 Millimeter
Device Size Text, specify0
Length83 Millimeter
Device Size Text, specify0
Length83 Millimeter
Device Size Text, specify0
Length83 Millimeter
Device Size Text, specify0
Length83 Millimeter
Device Size Text, specify0
Length83 Millimeter
Device Size Text, specify0
Length83 Millimeter
Device Size Text, specify0
Length83 Millimeter
Device Size Text, specify0
Length83 Millimeter
Device Size Text, specify0
Length83 Millimeter
Device Size Text, specify0
Length83 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100846832074815 [Primary]

FDA Product Code

JDCPROSTHESIS, ELBOW, CONSTRAINED, CEMENTED

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2022-03-25
Device Publish Date2020-08-12

On-Brand Devices [LATITUDE EV™]

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008468320739799030351
008468320739629030346
008468320739559030341
008468320729659030398
008468320729419030397
008468320729279030395
008468320725909039005
008468320725769039004
008468320725699039003
008468320725529039002
008468320725459039001
008468320725389039000
008468320725210830825
008468320725140830824
008468320725070830823
008468320724910830822
008468320724840830821
008468320724770830820
008468320724600830819
008468320724530830818
008468320724460830817
008468320724390830816
008468320748150030721
008468320748080030720
008468320747540030711
008468320747470030710
008468320746930030701
008468320746860030700

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