Conform Terino Malar Shell® CTMS-S4

GUDID M724CTMSS41

Malar Implant

IMPLANTECH ASSOCIATES, INC.

Malar prosthesis
Primary Device IDM724CTMSS41
NIH Device Record Key43872431-0214-4433-85ba-e8eebb85380e
Commercial Distribution StatusIn Commercial Distribution
Brand NameConform Terino Malar Shell®
Version Model NumberSize: Small
Catalog NumberCTMS-S4
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
HIBCCM724CTMSS41 [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

On-Brand Devices [Conform Terino Malar Shell®]

M724CTMSXL41Malar Implant
M724CTMSM41Malar Implant
M724CTMSS41Malar Implant
M724CTMSL41Malar Implant

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