ARTOURA Breast Tissue Expander SMXP130RH

GUDID 00081317024316

Smooth, High Profile, Suture Tabs, Integral Injection Dome, 475cc

MENTOR TEXAS L.P.

Skin-port tissue expander

• Primary Device ID: 00081317024316
• NIH Device Record Key: 9a42e948-0801-4776-93e4-ac6d1d4927ba
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ARTOURA Breast Tissue Expander
• Version Model Number: SMXP130RH
• Catalog Number: SMXP130RH
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00081317024316 [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: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-09-23
• Device Publish Date: 2016-07-01

On-Brand Devices [ARTOURA Breast Tissue Expander]

• 00081317024415: Smooth, Ultra High Profile, Suture Tabs, Integral Injection Dome, 850cc
• 00081317024408: Smooth, Ultra High Profile, Suture Tabs, Integral Injection Dome, 700cc
• 00081317024392: Smooth, Ultra High Profile, Suture Tabs, Integral Injection Dome, 650cc
• 00081317024385: Smooth, Ultra High Profile, Suture Tabs, Integral Injection Dome, 535cc
• 00081317024378: Smooth, Ultra High Profile, Suture Tabs, Integral Injection Dome, 455cc
• 00081317024361: Smooth, Ultra High Profile, Suture Tabs, Integral Injection Dome, 350cc
• 00081317024354: Smooth, High Profile, Suture Tabs, Integral Injection Dome, 850cc
• 00081317024347: Smooth, High Profile, Suture Tabs, Integral Injection Dome, 750cc
• 00081317024330: Smooth, High Profile, Suture Tabs, Integral Injection Dome, 600cc
• 00081317024323: Smooth, High Profile, Suture Tabs, Integral Injection Dome, 500cc
• 00081317024316: Smooth, High Profile, Suture Tabs, Integral Injection Dome, 475cc
• 00081317024309: Smooth, High Profile, Suture Tabs, Integral Injection Dome, 375cc
• 00081317024293: Smooth, High Profile, Suture Tabs, Integral Injection Dome, 300cc
• 00081317024286: Smooth, High Profile, Suture Tabs, Integral Injection Dome, 225cc
• 00081317009573: Textured, Ultra High Profile, Suture Tabs, Integral Injection Dome 850cc
• 00081317009566: Textured, Ultra High Profile, Suture Tabs, Integral Injection Dome 700cc
• 00081317009559: Textured, Ultra High Profile, Suture Tabs, Integral Injection Dome 650cc
• 00081317009542: Textured, Ultra High Profile, Suture Tabs, Integral Injection Dome 535cc
• 00081317009535: Textured, Ultra High Profile, Suture Tabs, Integral Injection Dome 455cc
• 00081317009528: Textured, Ultra High Profile, Suture Tabs, Integral Injection Dome 350cc
• 00081317009511: Textured, High Profile, Suture Tabs, Integral Injection Dome, 800cc
• 00081317009504: Textured, High Profile, Suture Tabs, Integral Injection Dome, 750cc
• 00081317009498: Textured, High Profile, Suture Tabs, Integral Injection Dome, 600cc
• 00081317009481: Textured, High Profile, Suture Tabs, Integral Injection Dome, 500cc
• 00081317009474: Textured, High Profile, Suture Tabs, Integral Injection Dome, 475cc
• 00081317009467: Textured, High Profile, Suture Tabs, Integral Injection Dome, 375cc
• 00081317009450: Textured, High Profile, Suture Tabs, Integral Injection Dome, 300cc
• 00081317009443: Textured, High Profile, Suture Tabs, Integral Injection Dome, 225cc