MENTOR MemoryGel Resterilizable Gel Sizer RSZ5295S

GUDID 00081317008224

Ultra High Profile, 295cc

MENTOR TEXAS L.P.

Invasive breast implant sizer, reusable Invasive breast implant sizer, fixed, reusable Invasive breast implant sizer, fixed, reusable Invasive breast implant sizer, fixed, reusable Invasive breast implant sizer, fixed, reusable Invasive breast implant sizer, fixed, reusable Invasive breast implant sizer, fixed, reusable Invasive breast implant sizer, fixed, reusable Invasive breast implant sizer, fixed, reusable Invasive breast implant sizer, fixed, reusable Invasive breast implant sizer, fixed, reusable Invasive breast implant sizer, fixed, reusable Invasive breast implant sizer, fixed, reusable Invasive breast implant sizer, fixed, reusable Invasive breast implant sizer, fixed, reusable Invasive breast implant sizer, fixed, reusable

• Primary Device ID: 00081317008224
• NIH Device Record Key: d1bc5cdd-130f-46be-a62d-20d1d40074e9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MENTOR MemoryGel Resterilizable Gel Sizer
• Version Model Number: RSZ5295S
• Catalog Number: RSZ5295S
• Company DUNS: 167450993
• Company Name: MENTOR TEXAS L.P.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)235-5731
• Email: xx@xx.xx
• Phone: +1(800)235-5731
• Email: xx@xx.xx
• Phone: +1(800)235-5731
• Email: xx@xx.xx
• Phone: +1(800)235-5731
• Email: xx@xx.xx
• Phone: +1(800)235-5731
• Email: xx@xx.xx
• Phone: +1(800)235-5731
• Email: xx@xx.xx
• Phone: +1(800)235-5731
• Email: xx@xx.xx
• Phone: +1(800)235-5731
• Email: xx@xx.xx
• Phone: +1(800)235-5731
• Email: xx@xx.xx
• Phone: +1(800)235-5731
• Email: xx@xx.xx
• Phone: +1(800)235-5731
• Email: xx@xx.xx
• Phone: +1(800)235-5731
• Email: xx@xx.xx
• Phone: +1(800)235-5731
• Email: xx@xx.xx
• Phone: +1(800)235-5731
• Email: xx@xx.xx
• Phone: +1(800)235-5731
• Email: xx@xx.xx
• Phone: +1(800)235-5731
• Email: xx@xx.xx

Device Identifiers

Device Issuing Agency	Device ID
GS1	00081317008224 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K062421

FDA Product Code

• MRD: SIZER, MAMMARY, BREAST IMPLANT VOLUME

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: true

[00081317008224]

Moist Heat or Steam Sterilization

[00081317008224]

Moist Heat or Steam Sterilization

[00081317008224]

Moist Heat or Steam Sterilization

[00081317008224]

Moist Heat or Steam Sterilization

[00081317008224]

Moist Heat or Steam Sterilization

[00081317008224]

Moist Heat or Steam Sterilization

[00081317008224]

Moist Heat or Steam Sterilization

[00081317008224]

Moist Heat or Steam Sterilization

[00081317008224]

Moist Heat or Steam Sterilization

[00081317008224]

Moist Heat or Steam Sterilization

[00081317008224]

Moist Heat or Steam Sterilization

[00081317008224]

Moist Heat or Steam Sterilization

[00081317008224]

Moist Heat or Steam Sterilization

[00081317008224]

Moist Heat or Steam Sterilization

[00081317008224]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-11-03

On-Brand Devices [MENTOR MemoryGel Resterilizable Gel Sizer]

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• 00081317008347: Ultra High Profile, 750cc
• 00081317008330: Ultra High Profile, 700cc
• 00081317008323: Ultra High Profile, 650cc
• 00081317008316: Ultra High Profile, 590cc
• 00081317008309: Ultra High Profile, 535cc
• 00081317008293: Ultra High Profile, 480cc
• 00081317008286: Ultra High Profile, 455cc
• 00081317008279: Ultra High Profile, 430cc
• 00081317008262: Ultra High Profile, 400cc
• 00081317008255: Ultra High Profile, 375cc
• 00081317008248: Ultra High Profile, 350cc
• 00081317008231: Ultra High Profile, 320cc
• 00081317008224: Ultra High Profile, 295cc
• 00081317008217: Ultra High Profile, 270cc
• 00081317008200: Ultra High Profile, 240cc
• 00081317008194: Ultra High Profile, 215cc
• 00081317008187: Ultra High Profile, 185cc
• 00081317008170: Ultra High Profile, 160cc
• 00081317008163: Ultra High Profile, 135cc
• 00081317008156: Moderate Classic Profile, 800cc
• 00081317008149: Moderate Classic Profile, 750cc
• 00081317008132: Moderate Classic Profile, 680cc
• 00081317008125: Moderate Classic Profile, 640cc
• 00081317008118: Moderate Classic Profile, 595cc
• 00081317008101: Moderate Classic Profile, 555cc
• 00081317008095: Moderate Classic Profile, 510cc
• 00081317008088: Moderate Classic Profile, 490cc
• 00081317008071: Moderate Classic Profile, 470cc
• 00081317008064: Moderate Classic Profile, 445cc
• 00081317008057: Moderate Classic Profile, 425cc
• 00081317008040: Moderate Classic Profile, 405cc
• 00081317008033: Moderate Classic Profile, 385cc
• 00081317008026: Moderate Classic Profile, 360cc
• 00081317008019: Moderate Classic Profile, 340cc
• 00081317008002: Moderate Classic Profile, 320cc
• 00081317007999: Moderate Classic Profile, 300cc
• 00081317007982: Moderate Classic Profile, 275cc
• 00081317007975: Moderate Classic Profile, 255cc
• 00081317007968: Moderate Classic Profile, 235cc
• 00081317007951: Moderate Classic Profile, 215cc
• 00081317007944: Moderate Classic Profile, 190cc
• 00081317007937: Moderate Classic Profile, 170cc
• 00081317007920: Moderate Classic Profile, 150cc
• 00081317007913: Moderate Classic Profile, 130cc
• 00081317007906: High Profile, 800cc
• 00081317007890: High Profile, 750cc
• 00081317007883: High Profile, 700cc
• 00081317007876: High Profile, 650cc
• 00081317007869: High Profile, 600cc