MENTOR Smooth Round Moderate Profile 3501630

GUDID 00081317001218

Saline Breast Implant with Diaphragm Valve, 225cc

MENTOR TEXAS L.P.

Saline-filled breast implant, unstructured

• Primary Device ID: 00081317001218
• NIH Device Record Key: f8111962-029f-48d3-b275-7293599f115b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MENTOR Smooth Round Moderate Profile
• Version Model Number: 3501630
• Catalog Number: 3501630
• 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: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00081317001218 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P990075

FDA Product Code

• FWM: Prosthesis, breast, inflatable, internal, saline

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: 2018-07-24
• Device Publish Date: 2014-09-17

On-Brand Devices [MENTOR Smooth Round Moderate Profile]

• 00081317001331: Saline Breast Implant with Diaphragm Valve, 700cc
• 00081317001324: Saline Breast Implant with Diaphragm Valve, 625cc
• 00081317001317: Saline Breast Implant with Diaphragm Valve, 575cc
• 00081317001300: Saline Breast Implant with Diaphragm Valve, 525cc
• 00081317001294: Saline Breast Implant with Diaphragm Valve, 475cc
• 00081317001287: Saline Breast Implant with Diaphragm Valve, 425cc
• 00081317001270: Saline Breast Implant with Diaphragm Valve, 375cc
• 00081317001263: Saline Breast Implant with Diaphragm Valve, 350cc
• 00081317001256: Saline Breast Implant with Diaphragm Valve, 325cc
• 00081317001249: Saline Breast Implant with Diaphragm Valve, 300cc
• 00081317001232: Saline Breast Implant with Diaphragm Valve, 275cc
• 00081317001225: Saline Breast Implant with Diaphragm Valve, 250cc
• 00081317001218: Saline Breast Implant with Diaphragm Valve, 225cc
• 00081317001201: Saline Breast Implant with Diaphragm Valve, 200cc
• 00081317001195: Saline Breast Implant with Diaphragm Valve, 175cc
• 00081317001188: Saline Breast Implant with Diaphragm Valve, 150cc
• 00081317001171: Saline Breast Implant with Diaphragm Valve, 125cc