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

GUDID M724SGRTSPEC44R1

Contoured Carving Block Implant

IMPLANTECH ASSOCIATES, INC.

Silicone-block tissue reconstructive material
Primary Device IDM724SGRTSPEC44R1
NIH Device Record Key129b89f3-4bc3-4788-8ee2-c048dd6fd337
Commercial Distribution StatusIn Commercial Distribution
Brand NameSG Pec Implant Style 4
Version Model NumberSize 4, Right
Catalog NumberSG-RTS-PEC 44R
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
HIBCCM724SGRTSPEC44R1 [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

On-Brand Devices [SG Pec Implant Style 4]

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M724SGRTSPEC41L1Contoured Carving Block Implant
M724SGRTSPEC43L1Contoured Carving Block Implant
M724SGRTSPEC42R1Contoured Carving Block Implant
M724SGRTSPEC41R1Contoured Carving Block Implant

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