MENTOR MemoryShape Resterilizable Gel Sizer RSZ4100S

GUDID 00081317025832

TH Tall Height, High Profile 250cc

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: 00081317025832
• NIH Device Record Key: 3614ae98-9f2b-402b-bb50-30412c9da89e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MENTOR MemoryShape Resterilizable Gel Sizer
• Version Model Number: RSZ4100S
• Catalog Number: RSZ4100S
• 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	00081317025832 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K151055

FDA Product Code

• MRD: SIZER, MAMMARY, BREAST IMPLANT VOLUME

Sterilization

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

[00081317025832]

Moist Heat or Steam Sterilization

[00081317025832]

Moist Heat or Steam Sterilization

[00081317025832]

Moist Heat or Steam Sterilization

[00081317025832]

Moist Heat or Steam Sterilization

[00081317025832]

Moist Heat or Steam Sterilization

[00081317025832]

Moist Heat or Steam Sterilization

[00081317025832]

Moist Heat or Steam Sterilization

[00081317025832]

Moist Heat or Steam Sterilization

[00081317025832]

Moist Heat or Steam Sterilization

[00081317025832]

Moist Heat or Steam Sterilization

[00081317025832]

Moist Heat or Steam Sterilization

[00081317025832]

Moist Heat or Steam Sterilization

[00081317025832]

Moist Heat or Steam Sterilization

[00081317025832]

Moist Heat or Steam Sterilization

[00081317025832]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-07-06
• Device Publish Date: 2018-02-28

On-Brand Devices [MENTOR MemoryShape Resterilizable Gel Sizer]

• 00081317025924: TH Tall Height, High Profile 755cc
• 00081317025917: TH Tall Height, High Profile 680cc
• 00081317025900: TH Tall Height, High Profile 610cc
• 00081317025894: TH Tall Height, High Profile 545cc
• 00081317025887: TH Tall Height, High Profile 485cc
• 00081317025870: TH Tall Height, High Profile 430cc
• 00081317025863: TH Tall Height, High Profile 380cc
• 00081317025856: TH Tall Height, High Profile 330cc
• 00081317025849: TH Tall Height, High Profile 290cc
• 00081317025832: TH Tall Height, High Profile 250cc
• 00081317025825: TH Tall Height, High Profile 215cc
• 00081317025818: TH Tall Height, High Profile 180cc