Tornier Perform® Reversed Augmented Glenoid DWJ502

GUDID 10846832062017

TORNIER, INC.

Reverse shoulder prosthesis base plate
Primary Device ID10846832062017
NIH Device Record Key0b2cdf98-6932-4b8a-894c-0cc1d67e3fc7
Commercial Distribution StatusIn Commercial Distribution
Brand NameTornier Perform® Reversed Augmented Glenoid
Version Model NumberDWJ502
Catalog NumberDWJ502
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
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 Diameter25 Millimeter
Outer Diameter25 Millimeter
Outer Diameter25 Millimeter
Outer Diameter25 Millimeter
Outer Diameter25 Millimeter
Outer Diameter25 Millimeter
Outer Diameter25 Millimeter
Outer Diameter25 Millimeter
Outer Diameter25 Millimeter
Outer Diameter25 Millimeter
Outer Diameter25 Millimeter
Outer Diameter25 Millimeter
Outer Diameter25 Millimeter
Outer Diameter25 Millimeter
Outer Diameter25 Millimeter
Outer Diameter25 Millimeter
Outer Diameter25 Millimeter
Outer Diameter25 Millimeter
Outer Diameter25 Millimeter
Outer Diameter25 Millimeter
Outer Diameter25 Millimeter
Outer Diameter25 Millimeter
Outer Diameter25 Millimeter
Outer Diameter25 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100846832092123 [Primary]
GS110846832062017 [Package]
Contains: 00846832092123
Package: [1 Units]
In Commercial Distribution

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 StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-05-18
Device Publish Date2022-05-10

On-Brand Devices [Tornier Perform® Reversed Augmented Glenoid]

10846832062048DWJ504
10846832062055DWJ515
10846832062031DWJ514
10846832062017DWJ502
10846832062062DWJ505
10846832062024DWJ503
10846832062000DWJ513
10846832061997DWJ512

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