MENTOR CPX 4 Breast Tissue Expander 3548116

GUDID 00081317006510

SILTEX Low Height Tissue Expander Style 8100, 750cc

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: 00081317006510
• NIH Device Record Key: da2b14b0-b0b0-4683-8a1b-3268c204c057
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MENTOR CPX 4 Breast Tissue Expander
• Version Model Number: 3548116
• Catalog Number: 3548116
• 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	00081317006510 [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]

• 00081317006640: SILTEX Tall Height Tissue Expander Style 8300, 850cc
• 00081317006633: SILTEX Tall Height Tissue Expander Style 8300, 750cc
• 00081317006626: SILTEX Tall Height Tissue Expander Style 8300, 650cc
• 00081317006619: SILTEX Tall Height Tissue Expander Style 8300, 550cc
• 00081317006602: SILTEX Tall Height Tissue Expander Style 8300, 450cc
• 00081317006596: SILTEX Tall Height Tissue Expander Style 8300, 350cc
• 00081317006589: SILTEX Tall Height Tissue Expander Style 8300, 250cc
• 00081317006572: SILTEX Medium Height Tissue Expander Style 8200, 800cc
• 00081317006565: SILTEX Medium Height Tissue Expander Style 8200, 650cc
• 00081317006558: SILTEX Medium Height Tissue Expander Style 8200, 550cc
• 00081317006541: SILTEX Medium Height Tissue Expander Style 8200, 450cc
• 00081317006534: SILTEX Medium Height Tissue Expander Style 8200, 350cc
• 00081317006527: SILTEX Medium Height Tissue Expander Style 8200, 275cc
• 00081317006510: SILTEX Low Height Tissue Expander Style 8100, 750cc
• 00081317006503: SILTEX Low Height Tissue Expander Style 8100, 650cc
• 00081317006497: SILTEX Low Height Tissue Expander Style 8100, 550cc
• 00081317006480: SILTEX Low Height Tissue Expander Style 8100, 450cc
• 00081317006473: SILTEX Low Height Tissue Expander Style 8100, 350cc
• 00081317006466: SILTEX Low Height Tissue Expander Style 8100, 250cc