TORNIER PERFORM™ Patient-Matched MWJ205

GUDID 00846832079445

TORNIER, INC.

Orthopaedic fixation implant alignment tool
Primary Device ID00846832079445
NIH Device Record Key473ba39f-d370-47e1-af17-4c1822265dcc
Commercial Distribution StatusIn Commercial Distribution
Brand NameTORNIER PERFORM™ Patient-Matched
Version Model NumberMWJ205
Catalog NumberMWJ205
Company DUNS968990812
Company NameTORNIER, INC.
Device Count1
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
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

Device Identifiers

Device Issuing AgencyDevice ID
GS100846832079445 [Primary]

FDA Product Code

PHXshoulder prosthesis, reverse configuration

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00846832079445]

Moist Heat or Steam Sterilization


[00846832079445]

Moist Heat or Steam Sterilization


[00846832079445]

Moist Heat or Steam Sterilization


[00846832079445]

Moist Heat or Steam Sterilization


[00846832079445]

Moist Heat or Steam Sterilization


[00846832079445]

Moist Heat or Steam Sterilization


[00846832079445]

Moist Heat or Steam Sterilization


[00846832079445]

Moist Heat or Steam Sterilization


[00846832079445]

Moist Heat or Steam Sterilization


[00846832079445]

Moist Heat or Steam Sterilization


[00846832079445]

Moist Heat or Steam Sterilization


[00846832079445]

Moist Heat or Steam Sterilization


[00846832079445]

Moist Heat or Steam Sterilization


[00846832079445]

Moist Heat or Steam Sterilization


[00846832079445]

Moist Heat or Steam Sterilization


[00846832079445]

Moist Heat or Steam Sterilization


[00846832079445]

Moist Heat or Steam Sterilization


[00846832079445]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2024-10-07
Device Publish Date2022-01-05

On-Brand Devices [TORNIER PERFORM™ Patient-Matched]

00846832079551DWJ610
00846832079544DWJ609
00846832079537DWJ608
00846832079520DWJ607
00846832079513DWJ606
00846832079506DWJ605
00846832079490DWJ604
00846832079483DWJ603
00846832079476DWJ602
00846832079469DWJ601
00846832079452MWJ204
00846832079445MWJ205
00846832079438MWJ203
00846832079421MWJ202
00846832079414MWJ201

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.