MENTOR CONTOUR PROFILE Single Use Saline Breast Implant Sizer 351-0711SZ

GUDID 00081317002987

CONTOUR PROFILE Saline Breast Implant Sizer, 275cc

MENTOR TEXAS L.P.

Invasive breast implant sizer, single-use Invasive breast implant sizer, fixed, single-use Invasive breast implant sizer, fixed, single-use Invasive breast implant sizer, fixed, single-use Invasive breast implant sizer, fixed, single-use Invasive breast implant sizer, fixed, single-use Invasive breast implant sizer, fixed, single-use Invasive breast implant sizer, fixed, single-use Invasive breast implant sizer, fixed, single-use Invasive breast implant sizer, fixed, single-use Invasive breast implant sizer, fixed, single-use Invasive breast implant sizer, fixed, single-use Invasive breast implant sizer, fixed, single-use Invasive breast implant sizer, fixed, single-use Invasive breast implant sizer, fixed, single-use Invasive breast implant sizer, fixed, single-use Invasive breast implant sizer, fixed, single-use Invasive breast implant sizer, fixed, single-use Invasive breast implant sizer, fixed, single-use Invasive breast implant sizer, fixed, single-use Invasive breast implant sizer, fixed, single-use Invasive breast implant sizer, fixed, single-use Invasive breast implant sizer, fixed, single-use Invasive breast implant sizer, fixed, single-use Invasive breast implant sizer, fixed, single-use Invasive breast implant sizer, fixed, single-use Invasive breast implant sizer, fixed, single-use Invasive breast implant sizer, fixed, single-use Invasive breast implant sizer, fixed, single-use Invasive breast implant sizer, fixed, single-use Invasive breast implant sizer, fixed, single-use Invasive breast implant sizer, fixed, single-use

• Primary Device ID: 00081317002987
• NIH Device Record Key: 39197fb5-a62b-4f67-b972-0f531068541f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MENTOR CONTOUR PROFILE Single Use Saline Breast Implant Sizer
• Version Model Number: 351-0711SZ
• Catalog Number: 351-0711SZ
• 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: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• 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
• 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	00081317002987 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K010709

FDA Product Code

• MRD: SIZER, MAMMARY, BREAST IMPLANT VOLUME

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-02-24
• Device Publish Date: 2016-05-16

On-Brand Devices [MENTOR CONTOUR PROFILE Single Use Saline Breast Implant Sizer]

• 00081317003021: CONTOUR PROFILE Saline Breast Implant Sizer, 650cc
• 00081317003014: CONTOUR PROFILE Saline Breast Implant Sizer, 550cc
• 00081317003007: CONTOUR PROFILE Saline Breast Implant Sizer, 450cc
• 00081317002994: CONTOUR PROFILE Saline Breast Implant Sizer, 350cc
• 00081317002987: CONTOUR PROFILE Saline Breast Implant Sizer, 275cc