Mittelman Melo-Labial Groove™ NLI-XL

GUDID M724NLIXL1

Malar Implant

IMPLANTECH ASSOCIATES, INC.

Malar prosthesis
Primary Device IDM724NLIXL1
NIH Device Record Key63988b35-f402-48ba-ad69-ca7f9e23ba90
Commercial Distribution StatusIn Commercial Distribution
Brand NameMittelman Melo-Labial Groove™
Version Model NumberSize: X-Large
Catalog NumberNLI-XL
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
HIBCCM724NLIXL1 [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 [Mittelman Melo-Labial Groove™]

M724NLIM1Malar Implant
M724NLIL1Malar Implant
M724NLIXL1Malar Implant
M724NLIS1Malar Implant

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