MENTOR MemoryGel Enhance Single Use Gel Sizer Ultra High Profile SZ-UHE-1135

GUDID 10081317032691

MENTOR MemoryGel Enhance Single Use Gel Sizer Ultra High Profile for use with SUHE-1135

MENTOR TEXAS L.P.

Invasive breast implant sizer, fixed, single-use

• Primary Device ID: 10081317032691
• NIH Device Record Key: a0721aca-b3b7-4356-9224-e886cf570013
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MENTOR MemoryGel Enhance Single Use Gel Sizer Ultra High Profile
• Version Model Number: SZUHE1135
• Catalog Number: SZ-UHE-1135
• 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: false
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	10081317032691 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K241552

FDA Product Code

• MRD: Mammary sizer

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: 2025-04-09
• Device Publish Date: 2025-04-01

On-Brand Devices [MENTOR MemoryGel Enhance Single Use Gel Sizer Ultra High Profile]

• 10081317032738: MENTOR MemoryGel Enhance Single Use Gel Sizer Ultra High Profile for use with SUHE-930
• 10081317032721: MENTOR MemoryGel Enhance Single Use Gel Sizer Ultra High Profile for use with SUHE-1445
• 10081317032714: MENTOR MemoryGel Enhance Single Use Gel Sizer Ultra High Profile for use with SUHE-1340
• 10081317032707: MENTOR MemoryGel Enhance Single Use Gel Sizer Ultra High Profile for use with SUHE-1240
• 10081317032691: MENTOR MemoryGel Enhance Single Use Gel Sizer Ultra High Profile for use with SUHE-1135
• 10081317032684: MENTOR MemoryGel Enhance Single Use Gel Sizer Ultra High Profile for use with SUHE-1030