MENTOR Round High Profile Single Use Saline Breast Implant Sizer 351-3500SZ

GUDID 00081317002963

Round High Profile Saline Breast Implant Sizer, 500cc

MENTOR TEXAS L.P.

Invasive breast implant sizer, single-use

• Primary Device ID: 00081317002963
• NIH Device Record Key: 500ebd13-3968-4a6b-94ee-a1f487b23950
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MENTOR Round High Profile Single Use Saline Breast Implant Sizer
• Version Model Number: 351-3500SZ
• Catalog Number: 351-3500SZ
• 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	00081317002963 [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 High Profile Single Use Saline Breast Implant Sizer]

• 00081317002970: Round High Profile Saline Breast Implant Sizer, 630cc
• 00081317002963: Round High Profile Saline Breast Implant Sizer, 500cc
• 00081317002956: Round High Profile Saline Breast Implant Sizer, 420cc
• 00081317002949: Round High Profile Saline Breast Implant Sizer, 380cc
• 00081317002932: Round High Profile Saline Breast Implant Sizer, 330cc
• 00081317002925: Round High Profile Saline Breast Implant Sizer, 310cc
• 00081317002918: Round High Profile Saline Breast Implant Sizer, 290cc
• 00081317002901: Round High Profile Saline Breast Implant Sizer, 270cc
• 00081317002895: Round High Profile Saline Breast Implant Sizer, 230cc
• 00081317002888: Round High Profile Saline Breast Implant Sizer, 190cc