MENTOR Smooth Round Moderate Profile 350-1630D

GUDID 10081317030604

Saline Breast Implant, 225cc

MENTOR TEXAS L.P.

Saline-filled breast implant, unstructured, smooth-surface

• Primary Device ID: 10081317030604
• NIH Device Record Key: f6a5b90d-395c-48d4-b7d9-bd6808166426
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MENTOR Smooth Round Moderate Profile
• Version Model Number: 3501630D
• Catalog Number: 350-1630D
• Company DUNS: 167450993
• Company Name: MENTOR TEXAS L.P.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Safe
• 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
• 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	10081317030604 [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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-03-25
• Device Publish Date: 2025-03-17

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
• 10081317030642: Saline Breast Implant, 325cc
• 10081317030635: Saline Breast Implant, 300cc
• 10081317030628: Saline Breast Implant, 275cc
• 10081317030611: Saline Breast Implant, 250cc
• 10081317030604: Saline Breast Implant, 225cc
• 10081317030598: Saline Breast Implant, 200cc
• 10081317030581: Saline Breast Implant, 175cc
• 10081317030574: Saline Breast Implant, 150cc
• 10081317030567: Saline Breast Implant, 125cc
• 10081317029035: Saline Breast Implant, 700cc
• 10081317029028: Saline Breast Implant, 625cc
• 10081317029011: Saline Breast Implant, 575cc
• 10081317029004: Saline Breast Implant, 525cc
• 10081317028991: Saline Breast Implant, 475cc
• 10081317028984: Saline Breast Implant, 425cc
• 10081317028977: Saline Breast Implant, 375cc
• 10081317028946: Saline Breast Implant, 350cc