Terino Malar Shell® TMS-XL5

GUDID M724TMSXL51

Malar Implant

IMPLANTECH ASSOCIATES, INC.

Malar prosthesis
Primary Device IDM724TMSXL51
NIH Device Record Key6ef1dc21-f840-4ad1-bd5f-781a02d4368e
Commercial Distribution StatusIn Commercial Distribution
Brand NameTerino Malar Shell®
Version Model NumberSize: X-Large (5mm)
Catalog NumberTMS-XL5
Company DUNS784664955
Company NameIMPLANTECH ASSOCIATES, 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 Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone1-800-733-0833
Emailinfo@implantech.com

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCM724TMSXL51 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LZKImplant, Malar

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-11-15
Device Publish Date2015-09-24

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