Combined Submalar Shell™ CSM-L

GUDID M724CSML1

Midfacial Implant

IMPLANTECH ASSOCIATES, INC.

Malar prosthesis
Primary Device IDM724CSML1
NIH Device Record Key81aa3ed7-91a8-40e7-a479-b6ca8abdf2df
Commercial Distribution StatusIn Commercial Distribution
Brand NameCombined Submalar Shell™
Version Model NumberSize: Large
Catalog NumberCSM-L
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
HIBCCM724CSML1 [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 [Combined Submalar Shell™]

M724CSMXL1Midfacial Implant
M724CSMS1Midfacial Implant
M724CSMM1Midfacial Implant
M724CSML1Midfacial Implant

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