MENTOR SILTEX Round Moderate Profile 3542630

GUDID 00081317001751

Saline Breast Implant with Diaphragm Valve, 225cc

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 ID00081317001751
NIH Device Record Keyc47c2927-7977-4f3e-9daa-26c377f34e68
Commercial Distribution StatusIn Commercial Distribution
Brand NameMENTOR SILTEX Round Moderate Profile
Version Model Number3542630
Catalog Number3542630
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
GS100081317001751 [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 Round Moderate Profile]

00081317001836Saline Breast Implant with Diaphragm Valve, 475cc
00081317001829Saline Breast Implant with Diaphragm Valve, 425cc
00081317001812Saline Breast Implant with Diaphragm Valve, 375cc
00081317001805Saline Breast Implant with Diaphragm Valve, 350cc
00081317001799Saline Breast Implant with Diaphragm Valve, 325cc
00081317001782Saline Breast Implant with Diaphragm Valve, 300cc
00081317001775Saline Breast Implant with Diaphragm Valve, 275cc
00081317001768Saline Breast Implant with Diaphragm Valve, 250cc
00081317001751Saline Breast Implant with Diaphragm Valve, 225cc
00081317001744Saline Breast Implant with Diaphragm Valve, 200cc
00081317001737Saline Breast Implant with Diaphragm Valve, 175cc
00081317001720Saline Breast Implant with Diaphragm Valve, 150cc
00081317001713Saline Breast Implant with Diaphragm Valve, 125cc

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