MENTOR Smooth Round Moderate Profile 3501610

GUDID 00081317001171

Saline Breast Implant with Diaphragm Valve, 125cc

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 ID00081317001171
NIH Device Record Key42f2dfab-169a-4611-9a1b-62fe48356dd5
Commercial Distribution StatusIn Commercial Distribution
Brand NameMENTOR Smooth Round Moderate Profile
Version Model Number3501610
Catalog Number3501610
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
GS100081317001171 [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 Smooth Round Moderate Profile]

00081317001331Saline Breast Implant with Diaphragm Valve, 700cc
00081317001324Saline Breast Implant with Diaphragm Valve, 625cc
00081317001317Saline Breast Implant with Diaphragm Valve, 575cc
00081317001300Saline Breast Implant with Diaphragm Valve, 525cc
00081317001294Saline Breast Implant with Diaphragm Valve, 475cc
00081317001287Saline Breast Implant with Diaphragm Valve, 425cc
00081317001270Saline Breast Implant with Diaphragm Valve, 375cc
00081317001263Saline Breast Implant with Diaphragm Valve, 350cc
00081317001256Saline Breast Implant with Diaphragm Valve, 325cc
00081317001249Saline Breast Implant with Diaphragm Valve, 300cc
00081317001232Saline Breast Implant with Diaphragm Valve, 275cc
00081317001225Saline Breast Implant with Diaphragm Valve, 250cc
00081317001218Saline Breast Implant with Diaphragm Valve, 225cc
00081317001201Saline Breast Implant with Diaphragm Valve, 200cc
00081317001195Saline Breast Implant with Diaphragm Valve, 175cc
00081317001188Saline Breast Implant with Diaphragm Valve, 150cc
00081317001171Saline Breast Implant with Diaphragm Valve, 125cc

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.