MENTOR MemoryGel Resterilizable Gel Sizer RSZ4004S

GUDID 00081317007807

High Profile, 400cc

MENTOR TEXAS L.P.

Invasive breast implant sizer, reusable

• Primary Device ID: 00081317007807
• NIH Device Record Key: 8384428f-cc61-4f70-b0c4-a0f2bcd6fcff
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MENTOR MemoryGel Resterilizable Gel Sizer
• Version Model Number: RSZ4004S
• Catalog Number: RSZ4004S
• 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	00081317007807 [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

[00081317007807]

Moist Heat or Steam Sterilization

[00081317007807]

Moist Heat or Steam Sterilization

[00081317007807]

Moist Heat or Steam Sterilization

[00081317007807]

Moist Heat or Steam Sterilization

[00081317007807]

Moist Heat or Steam Sterilization

[00081317007807]

Moist Heat or Steam Sterilization

[00081317007807]

Moist Heat or Steam Sterilization

[00081317007807]

Moist Heat or Steam Sterilization

[00081317007807]

Moist Heat or Steam Sterilization

[00081317007807]

Moist Heat or Steam Sterilization

[00081317007807]

Moist Heat or Steam Sterilization

[00081317007807]

Moist Heat or Steam Sterilization

[00081317007807]

Moist Heat or Steam Sterilization

[00081317007807]

Moist Heat or Steam Sterilization

[00081317007807]

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]

• 00081317008354: Ultra High Profile, 800cc
• 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