MENTOR Smooth Round Moderate Plus Profile 3502450

GUDID 00081317001454

Saline Breast Implant with Diaphragm Valve, 450cc

MENTOR TEXAS L.P.

Saline-filled breast implant, unstructured

• Primary Device ID: 00081317001454
• NIH Device Record Key: 8fd1557d-d978-4123-8119-59932d35a53d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MENTOR Smooth Round Moderate Plus Profile
• Version Model Number: 3502450
• Catalog Number: 3502450
• 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	00081317001454 [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 Plus Profile]

• 00081317001539: Saline Breast Implant with Diaphragm Valve, 800cc
• 00081317001522: Saline Breast Implant with Diaphragm Valve, 750cc
• 00081317001515: Saline Breast Implant with Diaphragm Valve, 700cc
• 00081317001508: Saline Breast Implant with Diaphragm Valve, 650cc
• 00081317001492: Saline Breast Implant with Diaphragm Valve, 600cc
• 00081317001485: Saline Breast Implant with Diaphragm Valve, 550cc
• 00081317001478: Saline Breast Implant with Diaphragm Valve, 500cc
• 00081317001461: Saline Breast Implant with Diaphragm Valve, 475cc
• 00081317001454: Saline Breast Implant with Diaphragm Valve, 450cc
• 00081317001447: Saline Breast Implant with Diaphragm Valve, 425cc
• 00081317001430: Saline Breast Implant with Diaphragm Valve, 400cc
• 00081317001423: Saline Breast Implant with Diaphragm Valve, 375cc
• 00081317001416: Saline Breast Implant with Diaphragm Valve, 350cc
• 00081317001409: Saline Breast Implant with Diaphragm Valve, 325cc
• 00081317001393: Saline Breast Implant with Diaphragm Valve, 300cc
• 00081317001386: Saline Breast Implant with Diaphragm Valve, 275cc
• 00081317001379: Saline Breast Implant with Diaphragm Valve, 250cc
• 00081317001362: Saline Breast Implant with Diaphragm Valve, 225cc
• 00081317001355: Saline Breast Implant with Diaphragm Valve, 200cc
• 00081317001348: Saline Breast Implant with Diaphragm Valve, 175cc