Terino Malar Shell® TMS-L3

GUDID M724TMSL31

Malar Implant

IMPLANTECH ASSOCIATES, INC.

Malar prosthesis
Primary Device IDM724TMSL31
NIH Device Record Key2e76140c-4b64-4789-bcb6-2b9a0bf64999
Commercial Distribution StatusIn Commercial Distribution
Brand NameTerino Malar Shell®
Version Model NumberSize: Large (3mm)
Catalog NumberTMS-L3
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
HIBCCM724TMSL31 [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 Date2019-11-14
Device Publish Date2015-09-24

On-Brand Devices [Terino Malar Shell® ]

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M724TMSS41Malar Implant
M724TMSS31Malar Implant
M724TMSM51Malar Implant
M724TMSM41Malar Implant
M724TMSM31Malar Implant
M724TMSL61Malar Implant
M724TMSL51Malar Implant
M724TMSL41Malar Implant
M724TMSL31Malar Implant
M724TMSXL51Malar Implant
M724TMSXL41Malar Implant

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