Simpliciti™

GUDID 00846832004829

TORNIER, INC.

Stem-fixed humeral head prosthesis
Primary Device ID00846832004829
NIH Device Record Keybbfc8950-20ba-4cfb-8aec-f3b2d0fba25c
Commercial Distribution StatusIn Commercial Distribution
Brand NameSimpliciti™
Version Model Number7122868
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 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

Device Dimensions

Outer Diameter39 Millimeter
Outer Diameter39 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100846832004829 [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 StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2015-10-16

On-Brand Devices [Simpliciti™]

00846832061440DWG403
00846832061433DWG402
00846832061426DWG401
008468320614197122891
008468320614027122890
008468320613967122889
008468320613897122888
008468320613727122887
008468320613657122886
008468320613587122885
008468320613417122884
008468320613347122883
008468320613277122882
008468320613107122881
008468320613037122880
008468320612977122879
008468320612807122878
008468320612737122877
008468320049047122876
008468320048987122875
008468320048817122874
008468320048747122873
008468320048677122872
008468320048507122871
008468320048437122870
008468320048367122869
008468320048297122868

Trademark Results [Simpliciti]

Mark Image

Registration | Serial
Company
Trademark
Application Date
SIMPLICITI
SIMPLICITI
78248717 not registered Dead/Abandoned
Simpliciti, Inc.
2003-05-12
SIMPLICITI
SIMPLICITI
77933746 4436760 Live/Registered
Tornier, Inc.
2010-02-11

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