MENTOR SILTEX CONTOUR PROFILE Moderate 3542913

GUDID 00081317001874

Saline Breast Implant with Diaphragm Valve, 350cc

MENTOR TEXAS L.P.

Saline-filled breast implant, unstructured Saline-filled breast implant, unstructured, textured-surface Saline-filled breast implant, unstructured, textured-surface Saline-filled breast implant, unstructured, textured-surface Saline-filled breast implant, unstructured, textured-surface Saline-filled breast implant, unstructured, textured-surface Saline-filled breast implant, unstructured, textured-surface Saline-filled breast implant, unstructured, textured-surface Saline-filled breast implant, unstructured, textured-surface Saline-filled breast implant, unstructured, textured-surface Saline-filled breast implant, unstructured, textured-surface Saline-filled breast implant, unstructured, textured-surface Saline-filled breast implant, unstructured, textured-surface Saline-filled breast implant, unstructured, textured-surface Saline-filled breast implant, unstructured, textured-surface Saline-filled breast implant, unstructured, textured-surface Saline-filled breast implant, unstructured, textured-surface
Primary Device ID00081317001874
NIH Device Record Key053bbf93-807f-4995-84a5-7bdf20d44340
Commercial Distribution StatusIn Commercial Distribution
Brand NameMENTOR SILTEX CONTOUR PROFILE Moderate
Version Model Number3542913
Catalog Number3542913
Company DUNS167450993
Company NameMENTOR TEXAS L.P.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numbertrue
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)235-5731
Emailxx@xx.xx
Phone+1(800)235-5731
Emailxx@xx.xx
Phone+1(800)235-5731
Emailxx@xx.xx
Phone+1(800)235-5731
Emailxx@xx.xx
Phone+1(800)235-5731
Emailxx@xx.xx
Phone+1(800)235-5731
Emailxx@xx.xx
Phone+1(800)235-5731
Emailxx@xx.xx
Phone+1(800)235-5731
Emailxx@xx.xx
Phone+1(800)235-5731
Emailxx@xx.xx
Phone+1(800)235-5731
Emailxx@xx.xx
Phone+1(800)235-5731
Emailxx@xx.xx
Phone+1(800)235-5731
Emailxx@xx.xx
Phone+1(800)235-5731
Emailxx@xx.xx
Phone+1(800)235-5731
Emailxx@xx.xx
Phone+1(800)235-5731
Emailxx@xx.xx
Phone+1(800)235-5731
Emailxx@xx.xx
Phone+1(800)235-5731
Emailxx@xx.xx

Device Identifiers

Device Issuing AgencyDevice ID
GS100081317001874 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FWMProsthesis, breast, inflatable, internal, saline

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2018-07-24
Device Publish Date2014-09-17

On-Brand Devices [MENTOR SILTEX CONTOUR PROFILE Moderate]

00081317001898Saline Breast Implant with Diaphragm Valve, 525cc
00081317001881Saline Breast Implant with Diaphragm Valve, 425cc
00081317001874Saline Breast Implant with Diaphragm Valve, 350cc
00081317001867Saline Breast Implant with Diaphragm Valve, 275cc
00081317001850Saline Breast Implant with Diaphragm Valve, 225cc
00081317001843Saline Breast Implant with Diaphragm Valve, 175cc

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