MENTOR Smooth Round High Profile 3503250

GUDID 00081317001607

Saline Breast Implant with Diaphragm Valve, 250cc

MENTOR TEXAS L.P.

Saline-filled breast implant, unstructured

• Primary Device ID: 00081317001607
• NIH Device Record Key: e26bf40a-db54-46f3-bef5-079383ed53c5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MENTOR Smooth Round High Profile
• Version Model Number: 3503250
• Catalog Number: 3503250
• 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	00081317001607 [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 High Profile]

• 00081317001706: Saline Breast Implant with Diaphragm Valve, 630cc
• 00081317001690: Saline Breast Implant with Diaphragm Valve, 560cc
• 00081317001683: Saline Breast Implant with Diaphragm Valve, 500cc
• 00081317001676: Saline Breast Implant with Diaphragm Valve, 460cc
• 00081317001669: Saline Breast Implant with Diaphragm Valve, 420cc
• 00081317001652: Saline Breast Implant with Diaphragm Valve, 380cc
• 00081317001645: Saline Breast Implant with Diaphragm Valve, 330cc
• 00081317001638: Saline Breast Implant with Diaphragm Valve, 310cc
• 00081317001621: Saline Breast Implant with Diaphragm Valve, 290cc
• 00081317001614: Saline Breast Implant with Diaphragm Valve, 270cc
• 00081317001607: Saline Breast Implant with Diaphragm Valve, 250cc
• 00081317001591: Saline Breast Implant with Diaphragm Valve, 230cc
• 00081317001584: Saline Breast Implant with Diaphragm Valve, 210cc
• 00081317001577: Saline Breast Implant with Diaphragm Valve, 190cc
• 00081317001560: Saline Breast Implant with Diaphragm Valve, 170cc