MENTOR SILTEX Round SPECTRUM 3542470M

GUDID 00081317002116

Post-Operatively Adjustable Saline Breast Implant, 425cc

MENTOR TEXAS L.P.

Saline-filled breast implant, unstructured
Primary Device ID00081317002116
NIH Device Record Key2469284a-4165-432e-a72b-9e814ae9fd76
Commercial Distribution StatusIn Commercial Distribution
Brand NameMENTOR SILTEX Round SPECTRUM
Version Model Number3542470M
Catalog Number3542470M
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
GS100081317002116 [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 SPECTRUM]

00081317002123Post-Operatively Adjustable Saline Breast Implant, 475cc
00081317002116Post-Operatively Adjustable Saline Breast Implant, 425cc
00081317002109Post-Operatively Adjustable Saline Breast Implant, 375cc
00081317002093Post-Operatively Adjustable Saline Breast Implant, 325cc
00081317002086Post-Operatively Adjustable Saline Breast Implant, 275cc
00081317002079Post-Operatively Adjustable Saline Breast Implant, 225cc
00081317002062Post-Operatively Adjustable Saline Breast Implant, 175cc
00081317002055Post-Operatively Adjustable Saline Breast Implant, 125cc

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