Made-To-Order 9028999

GUDID 00840338601667

Cut Ring 42

TORNIER, INC.

Osteotomy guide, reusable Osteotomy guide, reusable Osteotomy guide, reusable Osteotomy guide, reusable Osteotomy guide, reusable Osteotomy guide, reusable Osteotomy guide, reusable Osteotomy guide, reusable Osteotomy guide, reusable Osteotomy guide, reusable Osteotomy guide, reusable Osteotomy guide, reusable Osteotomy guide, reusable Osteotomy guide, reusable Osteotomy guide, reusable Osteotomy guide, reusable Osteotomy guide, reusable
Primary Device ID00840338601667
NIH Device Record Keyd72efaed-d89b-4802-a7dd-538880c71cd2
Commercial Distribution StatusIn Commercial Distribution
Brand NameMade-To-Order
Version Model Number9028999
Catalog Number9028999
Company DUNS968990812
Company NameTORNIER, INC.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
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 Datefalse
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

Device Dimensions

Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0

Device Identifiers

Device Issuing AgencyDevice ID
GS100840338601667 [Primary]

FDA Product Code

FZXGuide, surgical, instrument

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00840338601667]

Moist Heat or Steam Sterilization

[00840338601667]

Moist Heat or Steam Sterilization

[00840338601667]

Moist Heat or Steam Sterilization

[00840338601667]

Moist Heat or Steam Sterilization

[00840338601667]

Moist Heat or Steam Sterilization

[00840338601667]

Moist Heat or Steam Sterilization

[00840338601667]

Moist Heat or Steam Sterilization

[00840338601667]

Moist Heat or Steam Sterilization

[00840338601667]

Moist Heat or Steam Sterilization

[00840338601667]

Moist Heat or Steam Sterilization

[00840338601667]

Moist Heat or Steam Sterilization

[00840338601667]

Moist Heat or Steam Sterilization

[00840338601667]

Moist Heat or Steam Sterilization

[00840338601667]

Moist Heat or Steam Sterilization

[00840338601667]

Moist Heat or Steam Sterilization

[00840338601667]

Moist Heat or Steam Sterilization

[00840338601667]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-03-15
Device Publish Date2023-03-07

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