MENTOR Smooth Round SPECTRUM 3501430

GUDID 00081317001973

Post Operatively Adjustable Saline Breast Implant, 225cc

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 ID00081317001973
NIH Device Record Keyfb94baad-a5cb-4691-80fc-9540480dfbd9
Commercial Distribution StatusIn Commercial Distribution
Brand NameMENTOR Smooth Round SPECTRUM
Version Model Number3501430
Catalog Number3501430
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
GS100081317001973 [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 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

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