SG Pec Implant Style 4 SG-RTS-PEC 44L

GUDID M724SGRTSPEC44L1

Contoured Carving Block Implant

IMPLANTECH ASSOCIATES, INC.

Silicone-block tissue reconstructive material
Primary Device IDM724SGRTSPEC44L1
NIH Device Record Key22eea6c9-af1a-40ea-8084-64c26a193a78
Commercial Distribution StatusIn Commercial Distribution
Brand NameSG Pec Implant Style 4
Version Model NumberSize 4, Left
Catalog NumberSG-RTS-PEC 44L
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
HIBCCM724SGRTSPEC44L1 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MICImplant, Muscle, Pectoralis

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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