Temporal Shell Implant TS-07L

GUDID M724TS07L1

Temporal Implant

IMPLANTECH ASSOCIATES, INC.

Silicone-block tissue reconstructive material
Primary Device IDM724TS07L1
NIH Device Record Key53a0974c-935c-421d-a575-0e31e87e549c
Commercial Distribution StatusIn Commercial Distribution
Brand NameTemporal Shell Implant
Version Model NumberSize: 7mm, Left
Catalog NumberTS-07L
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
HIBCCM724TS07L1 [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 Date2019-11-15
Device Publish Date2015-09-24

On-Brand Devices [Temporal Shell Implant]

M724TS09R1Temporal Implant
M724TS07R1Temporal Implant
M724TS09L1Temporal Implant
M724TS07L1Temporal Implant

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