MENTOR ARTOURA PLUS, Smooth, Ultra High Profile SDC-120UH

GUDID 10081317028212

Breast Tissue Expander, Suture Tabs, Integral Injection Dome, 535cc

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

• Primary Device ID: 10081317028212
• NIH Device Record Key: 28e9e225-20d9-429d-b934-6f6c3dab33a4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MENTOR ARTOURA PLUS, Smooth, Ultra High Profile
• Version Model Number: SDC120UH
• Catalog Number: SDC-120UH
• 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)235-5740
• Email: xx@xx.xx
• Phone: +1(800)235-5740
• Email: xx@xx.xx
• Phone: +1(800)235-5740
• Email: xx@xx.xx
• Phone: +1(800)235-5740
• Email: xx@xx.xx
• Phone: +1(800)235-5740
• Email: xx@xx.xx
• Phone: +1(800)235-5740
• Email: xx@xx.xx
• Phone: +1(800)235-5740
• Email: xx@xx.xx
• Phone: +1(800)235-5740
• Email: xx@xx.xx
• Phone: +1(800)235-5740
• Email: xx@xx.xx
• Phone: +1(800)235-5740
• Email: xx@xx.xx
• Phone: +1(800)235-5740
• Email: xx@xx.xx
• Phone: +1(800)235-5740
• Email: xx@xx.xx
• Phone: +1(800)235-5740
• Email: xx@xx.xx
• Phone: +1(800)235-5740
• Email: xx@xx.xx

Device Identifiers

Device Issuing Agency	Device ID
GS1	10081317028212 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K161176

FDA Product Code

• LCJ: Expander, skin, inflatable

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-12-28
• Device Publish Date: 2020-12-18

On-Brand Devices [MENTOR ARTOURA PLUS, Smooth, Ultra High Profile]

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• 10081317028229: Breast Tissue Expander, Suture Tabs, Integral Injection Dome, 650cc
• 10081317028212: Breast Tissue Expander, Suture Tabs, Integral Injection Dome, 535cc
• 10081317028205: Breast Tissue Expander, Suture Tabs, Integral Injection Dome, 455cc
• 10081317028182: Breast Tissue Expander, Suture Tabs, Integral Injection Dome, 350cc