Tornier Simpliciti® Shoulder System 7122882

GUDID 00846832091942

TORNIER, INC.

Stem-fixed humeral head prosthesis
Primary Device ID00846832091942
NIH Device Record Keyff123d31-07e5-46c5-954a-d1f4c2ead801
Commercial Distribution StatusIn Commercial Distribution
Brand NameTornier Simpliciti® Shoulder System
Version Model Number7122882
Catalog Number7122882
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

Device Dimensions

Device Size Text, specify0
Outer Diameter44 Millimeter
Device Size Text, specify0
Outer Diameter44 Millimeter
Device Size Text, specify0
Outer Diameter44 Millimeter
Device Size Text, specify0
Outer Diameter44 Millimeter
Device Size Text, specify0
Outer Diameter44 Millimeter
Device Size Text, specify0
Outer Diameter44 Millimeter
Device Size Text, specify0
Outer Diameter44 Millimeter
Device Size Text, specify0
Outer Diameter44 Millimeter
Device Size Text, specify0
Outer Diameter44 Millimeter
Device Size Text, specify0
Outer Diameter44 Millimeter
Device Size Text, specify0
Outer Diameter44 Millimeter
Device Size Text, specify0
Outer Diameter44 Millimeter
Device Size Text, specify0
Outer Diameter44 Millimeter
Device Size Text, specify0
Outer Diameter44 Millimeter
Device Size Text, specify0
Outer Diameter44 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100846832091942 [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 Date2022-05-03
Device Publish Date2022-04-25

On-Brand Devices [Tornier Simpliciti® Shoulder System]

00846832091874DWG401
008468320920557122877
008468320920177122884
008468320919427122882
008468320919047122887
008468320918987122880
008468320918817122886
008468320918437122878
008468320917447122881
008468320917067122883
008468320916837122889
008468320916527122891
008468320915777122885
008468320915467122890
008468320915087122879
008468320914857122888
008468320905497122869
008468320905327122868
008468320904957122876
008468320904887122875
008468320904717122874
008468320904647122873
008468320904577122872
008468320904407122871
008468320904337122870

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