MENTOR MemoryGel BOOST Resterilizable Gel Sizer RSZ-HPB-235S

GUDID 00081317027393

High Profile BOOST, For Use With SHPB-235

MENTOR TEXAS L.P.

Invasive breast implant sizer, fixed, reusable
Primary Device ID00081317027393
NIH Device Record Key77addeee-9271-406c-bb70-c819df080586
Commercial Distribution StatusIn Commercial Distribution
Brand NameMENTOR MemoryGel BOOST Resterilizable Gel Sizer
Version Model NumberRSZHPB235S
Catalog NumberRSZ-HPB-235S
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
GS100081317027393 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MRDSIZER, MAMMARY, BREAST IMPLANT VOLUME

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[00081317027393]

Moist Heat or Steam Sterilization


[00081317027393]

Moist Heat or Steam Sterilization


[00081317027393]

Moist Heat or Steam Sterilization


[00081317027393]

Moist Heat or Steam Sterilization


[00081317027393]

Moist Heat or Steam Sterilization


[00081317027393]

Moist Heat or Steam Sterilization


[00081317027393]

Moist Heat or Steam Sterilization


[00081317027393]

Moist Heat or Steam Sterilization


[00081317027393]

Moist Heat or Steam Sterilization


[00081317027393]

Moist Heat or Steam Sterilization


[00081317027393]

Moist Heat or Steam Sterilization


[00081317027393]

Moist Heat or Steam Sterilization


[00081317027393]

Moist Heat or Steam Sterilization


[00081317027393]

Moist Heat or Steam Sterilization


[00081317027393]

Moist Heat or Steam Sterilization


[00081317027393]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-02-23
Device Publish Date2022-02-15

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

10081317030666High Profile BOOST, For Use With SHPB-325
00081317027539High Profile BOOST, For Use With SHPB-775
00081317027522High Profile BOOST, For Use With SHPB-740
00081317027515High Profile BOOST, For Use With SHPB-685
00081317027508High Profile BOOST, For Use With SHPB-635
00081317027492High Profile BOOST, For Use With SHPB-585
00081317027485High Profile BOOST, For Use With SHPB-545
00081317027478High Profile BOOST, For Use With SHPB-520
00081317027461High Profile BOOST, For Use With SHPB-480
00081317027454High Profile BOOST, For Use With SHPB-440
00081317027447High Profile BOOST, For Use With SHPB-405
00081317027430High Profile BOOST, For Use With SHPB-370
00081317027416High Profile BOOST, For Use With SHPB-285
00081317027409High Profile BOOST, For Use With SHPB-260
00081317027393High Profile BOOST, For Use With SHPB-235
00081317027386High Profile BOOST, For Use With SHPB-200
00081317027355Moderate Plus Profile BOOST, For Use With SMPB-730
00081317027348Moderate Plus Profile BOOST, For Use With SMPB-675
00081317027331Moderate Plus Profile BOOST, For Use With SMPB-630
00081317027324Moderate Plus Profile BOOST, For Use With SMPB-590
00081317027317Moderate Plus Profile BOOST, For Use With SMPB-545
00081317027300Moderate Plus Profile BOOST, For Use With SMPB-530
00081317027294Moderate Plus Profile BOOST, For Use With SMPB-480
00081317027287Moderate Plus Profile BOOST, For Use With SMPB-450
00081317027270Moderate Plus Profile BOOST, For Use With SMPB-430
00081317027263Moderate Plus Profile BOOST, For Use With SMPB-390
00081317027256Moderate Plus Profile BOOST, For Use With SMPB-340
00081317027249Moderate Plus Profile BOOST, For Use With SMPB-320
00081317027232Moderate Plus Profile BOOST, For Use With SMPB-290
00081317027225Moderate Plus Profile BOOST, For Use With SMPB-265
00081317027218Moderate Plus Profile BOOST, For Use With SMPB-235
00081317027201Moderate Plus Profile BOOST, For Use With SMPB-210
00081317027195Moderate Plus Profile BOOST, For Use With SMPB-185
00081317027188Moderate Plus Profile BOOST, For Use With SMPB-160
00081317027171Moderate Plus Profile BOOST, For Use With SMPB-130
10081317031526Moderate High Profile BOOST, For Use With SMHB-775
10081317031519Moderate High Profile BOOST, For Use With SMHB-700
10081317031502Moderate High Profile BOOST, For Use With SMHB-635
10081317031496Moderate High Profile BOOST, For Use With SMHB-580
10081317031489Moderate High Profile BOOST, For Use With SMHB-500
10081317031472Moderate High Profile BOOST, For Use With SMHB-470
10081317031465Moderate High Profile BOOST, For Use With SMHB-435
10081317031458Moderate High Profile BOOST, For Use With SMHB-400
10081317031441Moderate High Profile BOOST, For Use With SMHB-375
10081317031434Moderate High Profile BOOST, For Use With SMHB-355
10081317031427Moderate High Profile BOOST, For Use With SMHB-330
10081317031410Moderate High Profile BOOST, For Use With SMHB-310
10081317031403Moderate High Profile BOOST, For Use With SMHB-280
10081317031397Moderate High Profile BOOST, For Use With SMHB-260
10081317031380Moderate High Profile BOOST, For Use With SMHB-230

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