MENTOR SILTEX CONTOUR PROFILE SPECTRUM 3542515

GUDID 00081317002178

Post Operatively Adjustable Saline Breast Implant, 650cc

MENTOR TEXAS L.P.

Saline-filled breast implant, unstructured
Primary Device ID00081317002178
NIH Device Record Key1d35cea6-a809-43ae-8ba9-b1eb2ac41de7
Commercial Distribution StatusIn Commercial Distribution
Brand NameMENTOR SILTEX CONTOUR PROFILE SPECTRUM
Version Model Number3542515
Catalog Number3542515
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
GS100081317002178 [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 SPECTRUM]

00081317002178Post Operatively Adjustable Saline Breast Implant, 650cc
00081317002161Post Operatively Adjustable Saline Breast Implant, 550cc
00081317002154Post Operatively Adjustable Saline Breast Implant, 450cc
00081317002147Post Operatively Adjustable Saline Breast Implant, 350cc
00081317002130Post Operatively Adjustable Saline Breast Implant, 275cc

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