MENTOR CPX4 with Suture Tabs, Tall Height 3549336

GUDID 00081317009757

SILTEX Tall Height Tissue Expander Style 9300, 1445cc

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: 00081317009757
• NIH Device Record Key: 158938f9-2c3d-41c5-b8f7-c2f8bd1334e4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MENTOR CPX4 with Suture Tabs, Tall Height
• Version Model Number: 3549336
• Catalog Number: 3549336
• 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
• 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	00081317009757 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K152496

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: 2016-03-14

Devices Manufactured by MENTOR TEXAS L.P.

• 10081317031113 - MENTOR MemoryGel BOOST Breast Implant: 2023-08-03 Smooth Moderate High Profile, 435cc |Smooth|Round|Silicone|
• 10081317031120 - MENTOR MemoryGel BOOST Breast Implant: 2023-08-03 Smooth Moderate High Profile, 580cc |Smooth|Round|Silicone|
• 10081317031137 - MENTOR MemoryGel BOOST Breast Implant: 2023-08-03 Smooth Moderate High Profile, 470cc |Smooth|Round|Silicone|
• 10081317031144 - MENTOR MemoryGel BOOST Breast Implant: 2023-08-03 Smooth Moderate High Profile, 500cc |Smooth|Round|Silicone|
• 10081317031151 - MENTOR MemoryGel BOOST Breast Implant: 2023-08-03 Smooth Moderate High Profile, 545cc |Smooth|Round|Silicone|
• 10081317031175 - MENTOR MemoryGel BOOST Breast Implant: 2023-08-03 Smooth Moderate High Profile, 150cc |Smooth|Round|Silicone|
• 10081317031182 - MENTOR MemoryGel BOOST Breast Implant: 2023-08-03 Smooth Moderate High Profile, 170cc |Smooth|Round|Silicone|
• 10081317031199 - MENTOR MemoryGel BOOST Breast Implant: 2023-08-03 Smooth Moderate High Profile, 190cc |Smooth|Round|Silicone|