Tornier Simpliciti Shoulder System DWG402

GUDID 00846832091713

Nucleus

TORNIER, INC.

Stem-fixed humeral head prosthesis
Primary Device ID00846832091713
NIH Device Record Key1a50b8f2-f96c-44a2-b3ed-86203950fb50
Commercial Distribution StatusIn Commercial Distribution
Brand NameTornier Simpliciti Shoulder System
Version Model NumberDWG402
Catalog NumberDWG402
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

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Device Identifiers

Device Issuing AgencyDevice ID
GS100846832091713 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

PKCProsthesis, total anatomic shoulder, uncemented metaphyseal humeral stem with no diaphyseal incursion, semi-constrained

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-10-26
Device Publish Date2022-10-18

On-Brand Devices [Tornier Simpliciti Shoulder System]

00846832091713Nucleus
00846832091621Nucleus

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