MENTOR CPX 3 Breast Tissue Expander with Suturing Tabs 3547115

GUDID 00081317003656

SILTEX Low Height Tissue Expander Style 7100, 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: 00081317003656
• NIH Device Record Key: 7ecdeb66-2c6b-4a55-ad3d-125a9eb62957
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MENTOR CPX 3 Breast Tissue Expander with Suturing Tabs
• Version Model Number: 3547115
• Catalog Number: 3547115
• 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	00081317003656 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K011500

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 3 Breast Tissue Expander with Suturing Tabs]

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• 00081317003786: SILTEX Medium Height Tissue Expander Style 7300, 750cc
• 00081317003779: SILTEX Medium Height Tissue Expander Style 7300, 650cc
• 00081317003762: SILTEX Medium Height Tissue Expander Style 7300, 550cc
• 00081317003755: SILTEX Medium Height Tissue Expander Style 7300, 450cc
• 00081317003748: SILTEX Medium Height Tissue Expander Style 7300, 350cc
• 00081317003731: SILTEX Medium Height Tissue Expander Style 7300, 250cc
• 00081317003724: SILTEX Medium Height Tissue Expander Style 7200, 275cc
• 00081317003717: SILTEX Medium Height Tissue Expander Style 7200, 800cc
• 00081317003700: SILTEX Medium Height Tissue Expander Style 7200, 650cc
• 00081317003694: SILTEX Medium Height Tissue Expander Style 7200, 550cc
• 00081317003687: SILTEX Medium Height Tissue Expander Style 7200, 450cc
• 00081317003670: SILTEX Medium Height Tissue Expander Style 7200, 350cc
• 00081317003663: SILTEX Low Height Tissue Expander Style 7100, 750cc
• 00081317003656: SILTEX Low Height Tissue Expander Style 7100, 650cc
• 00081317003649: SILTEX Low Height Tissue Expander Style 7100, 550cc
• 00081317003632: SILTEX Low Height Tissue Expander Style 7100, 450cc
• 00081317003625: SILTEX Low Height Tissue Expander Style 7100, 350cc
• 00081317003618: SILTEX Low Height Tissue Expander Style 7100, 250cc