MENTOR Injection Domes with Stainless Steel TRUE LOCK Connection Systems 350-DOMPK

GUDID 00081317004059

Dome Pack

MENTOR TEXAS L.P.

Saline-filled breast implant, unstructured
Primary Device ID00081317004059
NIH Device Record Key7aaa39f3-2abd-4d32-b1d6-62554f58d909
Commercial Distribution StatusIn Commercial Distribution
Brand NameMENTOR Injection Domes with Stainless Steel TRUE LOCK Connection Systems
Version Model Number350-DOMPK
Catalog Number350-DOMPK
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 Numberfalse
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
GS100081317004059 [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

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10081317031137 - MENTOR MemoryGel BOOST Breast Implant2023-08-03 Smooth Moderate High Profile, 470cc |Smooth|Round|Silicone|
10081317031144 - MENTOR MemoryGel BOOST Breast Implant2023-08-03 Smooth Moderate High Profile, 500cc |Smooth|Round|Silicone|
10081317031151 - MENTOR MemoryGel BOOST Breast Implant2023-08-03 Smooth Moderate High Profile, 545cc |Smooth|Round|Silicone|
10081317031175 - MENTOR MemoryGel BOOST Breast Implant2023-08-03 Smooth Moderate High Profile, 150cc |Smooth|Round|Silicone|
10081317031182 - MENTOR MemoryGel BOOST Breast Implant2023-08-03 Smooth Moderate High Profile, 170cc |Smooth|Round|Silicone|
10081317031199 - MENTOR MemoryGel BOOST Breast Implant2023-08-03 Smooth Moderate High Profile, 190cc |Smooth|Round|Silicone|

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