Mentor CPX4 with suture tabs, low height, smooth 3509115

GUDID 00081317026624

Breast tissue expander, suture tabs, smooth, integral injection dome, 650CC

MENTOR TEXAS L.P.

Skin-port tissue expander Skin-port tissue expander Skin-port tissue expander Skin-port tissue expander Skin-port tissue expander Skin-port tissue expander Skin-port tissue expander Skin-port tissue expander Skin-port tissue expander Skin-port tissue expander Skin-port tissue expander Skin-port tissue expander Skin-port tissue expander Skin-port tissue expander Skin-port tissue expander Skin-port tissue expander Skin-port tissue expander

• Primary Device ID: 00081317026624
• NIH Device Record Key: b69a5df7-6a3e-43b2-8755-d3b48c48a61a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Mentor CPX4 with suture tabs, low height, smooth
• Version Model Number: 3509115
• Catalog Number: 3509115
• Company DUNS: 167450993
• Company Name: MENTOR TEXAS L.P.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• 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: true
• 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	00081317026624 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K182335

FDA Product Code

• LCJ: EXPANDER, SKIN, INFLATABLE

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2019-09-23
• Device Publish Date: 2018-11-13

On-Brand Devices [Mentor CPX4 with suture tabs, low height, smooth]

• 00081317026631: Breast tissue expander, suture tabs, smooth, integral injection dome, 750CC
• 00081317026624: Breast tissue expander, suture tabs, smooth, integral injection dome, 650CC
• 00081317026617: Breast tissue expander, suture tabs, smooth, integral injection dome, 550CC
• 00081317026600: Breast tissue expander, suture tabs, smooth, integral injection dome, 450CC
• 00081317026594: Breast tissue expander, suture tabs, smooth, integral injection dome, 350CC
• 00081317026587: Breast tissue expander, suture tabs, smooth, integral injection dome, 250CC