MENTOR Smooth Round High Profile 3503170

GUDID 00081317001560

Saline Breast Implant with Diaphragm Valve, 170cc

MENTOR TEXAS L.P.

Saline-filled breast implant, unstructured Saline-filled breast implant, unstructured, smooth-surface Saline-filled breast implant, unstructured, smooth-surface Saline-filled breast implant, unstructured, smooth-surface Saline-filled breast implant, unstructured, smooth-surface Saline-filled breast implant, unstructured, smooth-surface Saline-filled breast implant, unstructured, smooth-surface Saline-filled breast implant, unstructured, smooth-surface Saline-filled breast implant, unstructured, smooth-surface Saline-filled breast implant, unstructured, smooth-surface Saline-filled breast implant, unstructured, smooth-surface Saline-filled breast implant, unstructured, smooth-surface Saline-filled breast implant, unstructured, smooth-surface Saline-filled breast implant, unstructured, smooth-surface Saline-filled breast implant, unstructured, smooth-surface Saline-filled breast implant, unstructured, smooth-surface Saline-filled breast implant, unstructured, smooth-surface
Primary Device ID00081317001560
NIH Device Record Keyb65f15fb-f06e-4b72-9942-c89a4e3856f9
Commercial Distribution StatusIn Commercial Distribution
Brand NameMENTOR Smooth Round High Profile
Version Model Number3503170
Catalog Number3503170
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
GS100081317001560 [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

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00081317001690Saline Breast Implant with Diaphragm Valve, 560cc
00081317001683Saline Breast Implant with Diaphragm Valve, 500cc
00081317001676Saline Breast Implant with Diaphragm Valve, 460cc
00081317001669Saline Breast Implant with Diaphragm Valve, 420cc
00081317001652Saline Breast Implant with Diaphragm Valve, 380cc
00081317001645Saline Breast Implant with Diaphragm Valve, 330cc
00081317001638Saline Breast Implant with Diaphragm Valve, 310cc
00081317001621Saline Breast Implant with Diaphragm Valve, 290cc
00081317001614Saline Breast Implant with Diaphragm Valve, 270cc
00081317001607Saline Breast Implant with Diaphragm Valve, 250cc
00081317001591Saline Breast Implant with Diaphragm Valve, 230cc
00081317001584Saline Breast Implant with Diaphragm Valve, 210cc
00081317001577Saline Breast Implant with Diaphragm Valve, 190cc
00081317001560Saline Breast Implant with Diaphragm Valve, 170cc

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