MENTOR MemoryGel Xtra Resterilizable Gel Sizer RSZMPX605S

GUDID 00081317026112

Moderate Plus Profile Xtra, 605cc

MENTOR TEXAS L.P.

Invasive breast implant sizer, reusable
Primary Device ID00081317026112
NIH Device Record Key73236725-bae9-4f37-8890-260c10e4cb32
Commercial Distribution StatusIn Commercial Distribution
Brand NameMENTOR MemoryGel Xtra Resterilizable Gel Sizer
Version Model NumberRSZMPX605S
Catalog NumberRSZMPX605S
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 Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numbertrue
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
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

Device Identifiers

Device Issuing AgencyDevice ID
GS100081317026112 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MRDSIZER, MAMMARY, BREAST IMPLANT VOLUME

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[00081317026112]

Moist Heat or Steam Sterilization


[00081317026112]

Moist Heat or Steam Sterilization


[00081317026112]

Moist Heat or Steam Sterilization


[00081317026112]

Moist Heat or Steam Sterilization


[00081317026112]

Moist Heat or Steam Sterilization


[00081317026112]

Moist Heat or Steam Sterilization


[00081317026112]

Moist Heat or Steam Sterilization


[00081317026112]

Moist Heat or Steam Sterilization


[00081317026112]

Moist Heat or Steam Sterilization


[00081317026112]

Moist Heat or Steam Sterilization


[00081317026112]

Moist Heat or Steam Sterilization


[00081317026112]

Moist Heat or Steam Sterilization


[00081317026112]

Moist Heat or Steam Sterilization


[00081317026112]

Moist Heat or Steam Sterilization


[00081317026112]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2017-08-31

On-Brand Devices [MENTOR MemoryGel Xtra Resterilizable Gel Sizer]

00081317026556High Profile Xtra, For Use With THPX-765
00081317026549High Profile Xtra, For Use With THPX-725
00081317026532High Profile Xtra, For Use With THPX-680
00081317026525High Profile Xtra, For Use With THPX-620
00081317026518High Profile Xtra, For Use With THPX-570
00081317026501High Profile Xtra, For Use With THPX-545
00081317026495High Profile Xtra, For Use With THPX-515
00081317026488High Profile Xtra, For Use With THPX-470
00081317026471High Profile Xtra, For Use With THPX-455
00081317026464High Profile Xtra, For Use With THPX-425
00081317026457High Profile Xtra, For Use With THPX-405
00081317026440High Profile Xtra, For Use With THPX-365
00081317026433High Profile Xtra, For Use With THPX-340
00081317026426High Profile Xtra, For Use With THPX-325
00081317026419High Profile Xtra, For Use With THPX-285
00081317026402High Profile Xtra, For Use With THPX-255
00081317026396High Profile Xtra, For Use With THPX-230
00081317026389High Profile Xtra, For Use With THPX-200
00081317026372High Profile Xtra, For Use With THPX-175
00081317026365High Profile Xtra, For Use With THPX-150
00081317026358High Profile Xtra, For Use With SHPX-790
00081317026341High Profile Xtra, For Use With SHPX-755
00081317026334High Profile Xtra, For Use With SHPX-700
00081317026327High Profile Xtra, For Use With SHPX-650
00081317026310High Profile Xtra, For Use With SHPX-595
00081317026303High Profile Xtra, For Use With SHPX-560
00081317026297High Profile Xtra, For Use With SHPX-535
00081317026280High Profile Xtra, For Use With SHPX-490
00081317026273High Profile Xtra, For Use With SHPX-465
00081317026266High Profile Xtra, For Use With SHPX-450
00081317026259High Profile Xtra, For Use With SHPX-415
00081317026242High Profile Xtra, For Use With SHPX-380
00081317026235High Profile Xtra, For Use With SHPX-355
00081317026228High Profile Xtra, For Use With SHPX-335
00081317026211High Profile Xtra, For Use With SHPX-285
00081317026204High Profile Xtra, For Use With SHPX-260
00081317026198High Profile Xtra, For Use With SHPX-235
00081317026181High Profile Xtra, For Use With SHPX-200
00081317026174High Profile Xtra, For Use With SHPX-180
00081317026167High Profile Xtra, For Use With SHPX-150
00081317026150Moderate Plus Profile Xtra, 755cc
00081317026143Moderate Plus Profile Xtra, 685cc
00081317026136Moderate Plus Profile Xtra, 645cc
00081317026129Moderate Plus Profile Xtra, 630cc
00081317026112Moderate Plus Profile Xtra, 605cc
00081317026105Moderate Plus Profile Xtra, 560cc
00081317026099Moderate Plus Profile Xtra, 545cc
00081317026082Moderate Plus Profile Xtra, 525cc
00081317026075Moderate Plus Profile Xtra, 490cc
00081317026068Moderate Plus Profile Xtra, 465cc

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