MENTOR Smooth Round Moderate Plus Profile 3502550

GUDID 00081317001485

Saline Breast Implant with Diaphragm Valve, 550cc

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 ID00081317001485
NIH Device Record Keyc8022f83-3b1c-4739-a47f-5058525462e0
Commercial Distribution StatusIn Commercial Distribution
Brand NameMENTOR Smooth Round Moderate Plus Profile
Version Model Number3502550
Catalog Number3502550
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
GS100081317001485 [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 Plus Profile]

00081317001539Saline Breast Implant with Diaphragm Valve, 800cc
00081317001522Saline Breast Implant with Diaphragm Valve, 750cc
00081317001515Saline Breast Implant with Diaphragm Valve, 700cc
00081317001508Saline Breast Implant with Diaphragm Valve, 650cc
00081317001492Saline Breast Implant with Diaphragm Valve, 600cc
00081317001485Saline Breast Implant with Diaphragm Valve, 550cc
00081317001478Saline Breast Implant with Diaphragm Valve, 500cc
00081317001461Saline Breast Implant with Diaphragm Valve, 475cc
00081317001454Saline Breast Implant with Diaphragm Valve, 450cc
00081317001447Saline Breast Implant with Diaphragm Valve, 425cc
00081317001430Saline Breast Implant with Diaphragm Valve, 400cc
00081317001423Saline Breast Implant with Diaphragm Valve, 375cc
00081317001416Saline Breast Implant with Diaphragm Valve, 350cc
00081317001409Saline Breast Implant with Diaphragm Valve, 325cc
00081317001393Saline Breast Implant with Diaphragm Valve, 300cc
00081317001386Saline Breast Implant with Diaphragm Valve, 275cc
00081317001379Saline Breast Implant with Diaphragm Valve, 250cc
00081317001362Saline Breast Implant with Diaphragm Valve, 225cc
00081317001355Saline Breast Implant with Diaphragm Valve, 200cc
00081317001348Saline Breast Implant with Diaphragm Valve, 175cc

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