MENTOR Smooth Round SPECTRUM 350-1490D

GUDID 10081317030550

Saline Breast Implant, 575cc

MENTOR TEXAS L.P.

Saline-filled breast implant, unstructured, smooth-surface
Primary Device ID10081317030550
NIH Device Record Keyfa1295f2-2f67-41d5-ae64-2a96621591e8
Commercial Distribution StatusIn Commercial Distribution
Brand NameMENTOR Smooth Round SPECTRUM
Version Model Number3501490D
Catalog Number350-1490D
Company DUNS167450993
Company NameMENTOR TEXAS L.P.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Conditional
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

Device Identifiers

Device Issuing AgencyDevice ID
GS110081317030550 [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 StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-03-25
Device Publish Date2025-03-17

On-Brand Devices [MENTOR Smooth Round SPECTRUM]

00081317002048Post Operatively Adjustable Saline Breast Implant, 575cc
00081317002031Post Operatively Adjustable Saline Breast Implant, 525cc
00081317002024Post Operatively Adjustable Saline Breast Implant, 475cc
00081317002017Post Operatively Adjustable Saline Breast Implant, 425cc
00081317002000Post Operatively Adjustable Saline Breast Implant, 375cc
00081317001997Post Operatively Adjustable Saline Breast Implant, 325cc
00081317001980Post Operatively Adjustable Saline Breast Implant, 275cc
00081317001973Post Operatively Adjustable Saline Breast Implant, 225cc
00081317001966Post Operatively Adjustable Saline Breast Implant, 175cc
00081317001959Post Operatively Adjustable Saline Breast Implant, 125cc
10081317030550Saline Breast Implant, 575cc
10081317030543Saline Breast Implant, 525cc
10081317030536Saline Breast Implant, 475cc
10081317030529Saline Breast Implant, 425cc
10081317030512Saline Breast Implant, 375cc
10081317030505Saline Breast Implant, 325cc
10081317030499Saline Breast Implant, 275cc
10081317030482Saline Breast Implant, 225cc
10081317030475Saline Breast Implant, 175cc
10081317030468Saline Breast Implant, 125cc

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