DT MedTech LLC 322515

GUDID B095322515

H2 PE INLAY SIZE 5 - LEFT ‐ 5MM/ANTERIOR

DT MEDTECH, LLC

Ankle prosthesis bearing
Primary Device IDB095322515
NIH Device Record Keyc50130ad-32a3-4773-a034-0ba60c89d9b7
Commercial Distribution StatusIn Commercial Distribution
Brand NameDT MedTech LLC
Version Model Number1
Catalog Number322515
Company DUNS080101891
Company NameDT MEDTECH, LLC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Conditional
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone410-427-0003
Emailquality@dtmedtech.com
Phone410-427-0003
Emailquality@dtmedtech.com
Phone410-427-0003
Emailquality@dtmedtech.com
Phone410-427-0003
Emailquality@dtmedtech.com
Phone410-427-0003
Emailquality@dtmedtech.com
Phone410-427-0003
Emailquality@dtmedtech.com
Phone410-427-0003
Emailquality@dtmedtech.com
Phone410-427-0003
Emailquality@dtmedtech.com
Phone410-427-0003
Emailquality@dtmedtech.com
Phone410-427-0003
Emailquality@dtmedtech.com
Phone410-427-0003
Emailquality@dtmedtech.com
Phone410-427-0003
Emailquality@dtmedtech.com
Phone410-427-0003
Emailquality@dtmedtech.com
Phone410-427-0003
Emailquality@dtmedtech.com
Phone410-427-0003
Emailquality@dtmedtech.com
Phone410-427-0003
Emailquality@dtmedtech.com
Phone999-999-9999
Emailquality@dtmedtech.com
Phone999-999-9999
Emailquality@dtmedtech.com
Phone999-999-9999
Emailquality@dtmedtech.com
Phone999-999-9999
Emailquality@dtmedtech.com
Phone999-999-9999
Emailquality@dtmedtech.com
Phone999-999-9999
Emailquality@dtmedtech.com
Phone999-999-9999
Emailquality@dtmedtech.com
Phone999-999-9999
Emailquality@dtmedtech.com
Phone999-999-9999
Emailquality@dtmedtech.com
Phone999-999-9999
Emailquality@dtmedtech.com
Phone999-999-9999
Emailquality@dtmedtech.com
Phone999-999-9999
Emailquality@dtmedtech.com
Phone999-999-9999
Emailquality@dtmedtech.com
Phone999-999-9999
Emailquality@dtmedtech.com
Phone999-999-9999
Emailquality@dtmedtech.com

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB095322515 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HSNProsthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number2
Public Version Date2018-07-06
Device Publish Date2018-03-20

Devices Manufactured by DT MEDTECH, LLC

B095301201 - Hintermann Series H32024-02-28 H3 TIBIAL COMPONENT RIGHT SIZE 1
B095301202 - Hintermann Series H32024-02-28 H3 TIBIAL COMPONENT RIGHT SIZE 2
B095301203 - Hintermann Series H32024-02-28 H3 TIBIAL COMPONENT RIGHT SIZE 3
B095301204 - Hintermann Series H32024-02-28 H3 TIBIAL COMPONENT RIGHT SIZE 4
B095301205 - Hintermann Series H32024-02-28 H3 TIBIAL COMPONENT RIGHT SIZE 5
B095301206 - Hintermann Series H32024-02-28 H3 TIBIAL COMPONENT RIGHT SIZE 6
B095300205 - Hintermann Series H32024-02-27 H3 PE INLAY SIZE 2 - 5mm
B095300206 - Hintermann Series H32024-02-27 H3 PE INLAY SIZE 2 - 6mm

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