MENTOR SILTEX CONTOUR PROFILE High 3542715

GUDID 00081317001942

Saline Breast Implant with Diaphragm Valve, 650cc

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 ID00081317001942
NIH Device Record Key69493924-1ac5-48c3-bafd-cbbc3568d158
Commercial Distribution StatusIn Commercial Distribution
Brand NameMENTOR SILTEX CONTOUR PROFILE High
Version Model Number3542715
Catalog Number3542715
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
GS100081317001942 [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 High]

00081317001942Saline Breast Implant with Diaphragm Valve, 650cc
00081317001935Saline Breast Implant with Diaphragm Valve, 550cc
00081317001928Saline Breast Implant with Diaphragm Valve, 450cc
00081317001911Saline Breast Implant with Diaphragm Valve, 350cc
00081317001904Saline Breast Implant with Diaphragm Valve, 275cc

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