DWD014

GUDID 03700386929892

CEMENT KIT FOR PEGGED GLENOID

TORNIER

Orthopaedic cement preparation/delivery kit
Primary Device ID03700386929892
NIH Device Record Key06245c55-8aba-4875-adea-72a7431582eb
Commercial Distribution StatusIn Commercial Distribution
Version Model NumberDWD014
Catalog NumberDWD014
Company DUNS260324876
Company NameTORNIER
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
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+330476613500
Emailorder@tornier.com
Phone+330476613500
Emailorder@tornier.com
Phone+330476613500
Emailorder@tornier.com
Phone+330476613500
Emailorder@tornier.com
Phone+330476613500
Emailorder@tornier.com
Phone+330476613500
Emailorder@tornier.com
Phone+330476613500
Emailorder@tornier.com
Phone+330476613500
Emailorder@tornier.com
Phone+330476613500
Emailorder@tornier.com
Phone+330476613500
Emailorder@tornier.com
Phone+330476613500
Emailorder@tornier.com
Phone+330476613500
Emailorder@tornier.com

Device Identifiers

Device Issuing AgencyDevice ID
GS103700386929892 [Primary]

FDA Product Code

JDZMIXER, CEMENT, FOR CLINICAL USE

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-12-09
Device Publish Date2022-12-01

Devices Manufactured by TORNIER

03700386915260 - AEQUALIS2026-02-18
03700386916144 - AEQUALIS REVERSED2026-02-18
03700386916151 - AEQUALIS REVERSED2026-02-18
03700386916618 - AEQUALIS REVERSED2026-02-18
03700386916731 - AEQUALIS REVERSED2026-02-18
03700386931529 - AEQUALIS REVERSED ADAPTER2026-02-18
03700386931536 - AEQUALIS REVERSED ADAPTER2026-02-18
03700386931543 - AEQUALIS REVERSED ADAPTER2026-02-18

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