MENTOR Round Moderate Profile Single Use Saline Breast Implant Sizer 351-375SZ

GUDID 00081317002659

Round Moderate Profile Saline Breast Implant Sizer, 375cc

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

• Primary Device ID: 00081317002659
• NIH Device Record Key: 6572dff6-b859-4cb0-8c21-1e52bf3452c5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MENTOR Round Moderate Profile Single Use Saline Breast Implant Sizer
• Version Model Number: 351-375SZ
• Catalog Number: 351-375SZ
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00081317002659 [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 Round Moderate Profile Single Use Saline Breast Implant Sizer]

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• 00081317002666: Round Moderate Profile Saline Breast Implant Sizer, 425cc
• 00081317002659: Round Moderate Profile Saline Breast Implant Sizer, 375cc
• 00081317002642: Round Moderate Profile Saline Breast Implant Sizer, 325cc
• 00081317002635: Round Moderate Profile Saline Breast Implant Sizer, 275cc
• 00081317002628: Round Moderate Profile Saline Breast Implant Sizer, 225cc
• 00081317002611: Round Moderate Profile Saline Breast Implant Sizer, 175cc
• 00081317002604: Round Moderate Profile Saline Breast Implant Sizer, 125cc