MENTOR MemoryShape Resterilizable Gel Sizer RSZ4125S

GUDID 00081317025887

TH Tall Height, High Profile 485cc

MENTOR TEXAS L.P.

Invasive breast implant sizer, reusable

• Primary Device ID: 00081317025887
• NIH Device Record Key: 11d4e8fb-2492-427c-b86d-0ad554de8ab0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MENTOR MemoryShape Resterilizable Gel Sizer
• Version Model Number: RSZ4125S
• Catalog Number: RSZ4125S
• 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	00081317025887 [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

[00081317025887]

Moist Heat or Steam Sterilization

[00081317025887]

Moist Heat or Steam Sterilization

[00081317025887]

Moist Heat or Steam Sterilization

[00081317025887]

Moist Heat or Steam Sterilization

[00081317025887]

Moist Heat or Steam Sterilization

[00081317025887]

Moist Heat or Steam Sterilization

[00081317025887]

Moist Heat or Steam Sterilization

[00081317025887]

Moist Heat or Steam Sterilization

[00081317025887]

Moist Heat or Steam Sterilization

[00081317025887]

Moist Heat or Steam Sterilization

[00081317025887]

Moist Heat or Steam Sterilization

[00081317025887]

Moist Heat or Steam Sterilization

[00081317025887]

Moist Heat or Steam Sterilization

[00081317025887]

Moist Heat or Steam Sterilization

[00081317025887]

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