MENTOR CPX 4 Breast Tissue Expander with Suture Tabs 3549315

GUDID 00081317006817

SILTEX Tall Height Tissue Expander Style 9300, 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: 00081317006817
• NIH Device Record Key: 8fd3f56a-bc3e-4613-967b-f464b9fd4fdc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MENTOR CPX 4 Breast Tissue Expander with Suture Tabs
• Version Model Number: 3549315
• Catalog Number: 3549315
• 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: 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	00081317006817 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K130813

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: 4
• Public Version Date: 2019-09-23
• Device Publish Date: 2015-09-07

On-Brand Devices [MENTOR CPX 4 Breast Tissue Expander with Suture Tabs]

• 00081317006831: SILTEX Tall Height Tissue Expander Style 9300, 850cc
• 00081317006824: SILTEX Tall Height Tissue Expander Style 9300, 750cc
• 00081317006817: SILTEX Tall Height Tissue Expander Style 9300, 650cc
• 00081317006800: SILTEX Tall Height Tissue Expander Style 9300, 550cc
• 00081317006794: SILTEX Tall Height Tissue Expander Style 9300, 450cc
• 00081317006787: SILTEX Tall Height Tissue Expander Style 9300, 350cc
• 00081317006770: SILTEX Tall Height Tissue Expander Style 9300, 250cc
• 00081317006763: SILTEX Medium Height Tissue Expander Style 9200, 800cc
• 00081317006756: SILTEX Medium Height Tissue Expander Style 9200, 650cc
• 00081317006749: SILTEX Medium Height Tissue Expander Style 9200, 550cc
• 00081317006732: SILTEX Medium Height Tissue Expander Style 9200, 450cc
• 00081317006725: SILTEX Medium Height Tissue Expander Style 9200, 350cc
• 00081317006718: SILTEX Medium Height Tissue Expander Style 9200, 275cc
• 00081317006701: SILTEX Low Height Tissue Expander Style 9100, 750cc
• 00081317006695: SILTEX Low Height Tissue Expander Style 9100, 650cc
• 00081317006688: SILTEX Low Height Tissue Expander Style 9100, 550cc
• 00081317006671: SILTEX Low Height Tissue Expander Style 9100, 450cc
• 00081317006664: SILTEX Low Height Tissue Expander Style 9100, 350cc
• 00081317006657: SILTEX Low Height Tissue Expander Style 9100, 250cc