Posterior Mandibular Angle™ TMA-10L

GUDID M724TMA10L1

Mandibular Implant

IMPLANTECH ASSOCIATES, INC.

Facial mandibular prosthesis
Primary Device IDM724TMA10L1
NIH Device Record Keyc95c265c-0f1f-4d8d-a1b5-bdbc4b8e165a
Commercial Distribution StatusIn Commercial Distribution
Brand NamePosterior Mandibular Angle™
Version Model NumberSize: 10, Left
Catalog NumberTMA-10L
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
HIBCCM724TMA10L1 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FWPProsthesis, Chin, Internal

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

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