MENTOR MemoryShape TM Plus Resterilizable Gel Sizer RSZ1459S

GUDID 00081317009016

Tall Height, Moderate Plus Profile Sterile, 615cc

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: 00081317009016
• NIH Device Record Key: c060abd8-8437-43b2-b35d-dabd0b59993c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MENTOR MemoryShape TM Plus Resterilizable Gel Sizer
• Version Model Number: RSZ1459S
• Catalog Number: RSZ1459S
• 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	00081317009016 [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

[00081317009016]

Moist Heat or Steam Sterilization

[00081317009016]

Moist Heat or Steam Sterilization

[00081317009016]

Moist Heat or Steam Sterilization

[00081317009016]

Moist Heat or Steam Sterilization

[00081317009016]

Moist Heat or Steam Sterilization

[00081317009016]

Moist Heat or Steam Sterilization

[00081317009016]

Moist Heat or Steam Sterilization

[00081317009016]

Moist Heat or Steam Sterilization

[00081317009016]

Moist Heat or Steam Sterilization

[00081317009016]

Moist Heat or Steam Sterilization

[00081317009016]

Moist Heat or Steam Sterilization

[00081317009016]

Moist Heat or Steam Sterilization

[00081317009016]

Moist Heat or Steam Sterilization

[00081317009016]

Moist Heat or Steam Sterilization

[00081317009016]

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 MemoryShape TM Plus Resterilizable Gel Sizer]

• 00081317009023: Tall Height, Moderate Plus Profile Sterile, 680cc
• 00081317009016: Tall Height, Moderate Plus Profile Sterile, 615cc
• 00081317009009: Tall Height, Moderate Plus Profile Sterile, 555cc
• 00081317008996: Tall Height, Moderate Plus Profile Sterile, 495cc
• 00081317008989: Tall Height, Moderate Plus Profile Sterile, 445cc
• 00081317008972: Tall Height, Moderate Plus Profile Sterile, 395cc
• 00081317008965: Tall Height, Moderate Plus Profile Sterile, 350cc
• 00081317008958: Tall Height, Moderate Plus Profile Sterile, 305cc
• 00081317008941: Tall Height, Moderate Plus Profile Sterile, 270cc
• 00081317008934: Tall Height, Moderate Plus Profile Sterile, 235cc
• 00081317008927: Tall Height, Moderate Plus Profile Sterile, 205cc
• 00081317008910: Tall Height, Moderate Plus Profile Sterile, 175cc
• 00081317008903: Tall Height, Moderate Plus Profile Sterile, 145cc