ePTFE Midfacial ESMF-S

GUDID M724ESMFS1

Midfacial Implant

IMPLANTECH ASSOCIATES, INC.

Malar prosthesis
Primary Device IDM724ESMFS1
NIH Device Record Key7bd790a1-d496-47b8-adfd-d56125b864f8
Commercial Distribution StatusIn Commercial Distribution
Brand NameePTFE Midfacial
Version Model NumberSize: Small
Catalog NumberESMF-S
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
HIBCCM724ESMFS1 [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 Number2
Public Version Date2019-11-15
Device Publish Date2019-06-14

On-Brand Devices [ePTFE Midfacial]

M724ESMFS1Midfacial Implant
M724ESMFM1Midfacial Implant
M724ESMFL1Midfacial Implant

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