MENTOR MemoryShape LM Plus Resterilizable Gel Sizer RSZ1357S

GUDID 00081317008859

Low Height, Moderate Plus Profile Sterile, 415cc

MENTOR TEXAS L.P.

Invasive breast implant sizer, reusable Invasive breast implant sizer, fixed, reusable Invasive breast implant sizer, fixed, reusable Invasive breast implant sizer, fixed, reusable Invasive breast implant sizer, fixed, reusable Invasive breast implant sizer, fixed, reusable Invasive breast implant sizer, fixed, reusable Invasive breast implant sizer, fixed, reusable Invasive breast implant sizer, fixed, reusable Invasive breast implant sizer, fixed, reusable Invasive breast implant sizer, fixed, reusable Invasive breast implant sizer, fixed, reusable Invasive breast implant sizer, fixed, reusable Invasive breast implant sizer, fixed, reusable Invasive breast implant sizer, fixed, reusable Invasive breast implant sizer, fixed, reusable

• Primary Device ID: 00081317008859
• NIH Device Record Key: 40ea7fe0-e9d8-49f5-adb5-2a643736da92
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MENTOR MemoryShape LM Plus Resterilizable Gel Sizer
• Version Model Number: RSZ1357S
• Catalog Number: RSZ1357S
• 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: false
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00081317008859 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K151055

FDA Product Code

• MRD: SIZER, MAMMARY, BREAST IMPLANT VOLUME

Sterilization

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

[00081317008859]

Moist Heat or Steam Sterilization

[00081317008859]

Moist Heat or Steam Sterilization

[00081317008859]

Moist Heat or Steam Sterilization

[00081317008859]

Moist Heat or Steam Sterilization

[00081317008859]

Moist Heat or Steam Sterilization

[00081317008859]

Moist Heat or Steam Sterilization

[00081317008859]

Moist Heat or Steam Sterilization

[00081317008859]

Moist Heat or Steam Sterilization

[00081317008859]

Moist Heat or Steam Sterilization

[00081317008859]

Moist Heat or Steam Sterilization

[00081317008859]

Moist Heat or Steam Sterilization

[00081317008859]

Moist Heat or Steam Sterilization

[00081317008859]

Moist Heat or Steam Sterilization

[00081317008859]

Moist Heat or Steam Sterilization

[00081317008859]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-11-03

On-Brand Devices [MENTOR MemoryShape LM Plus Resterilizable Gel Sizer]

• 00081317008897: Low Height, Moderate Plus Profile Sterile, 690cc
• 00081317008880: Low Height, Moderate Plus Profile Sterile, 570cc
• 00081317008873: Low Height, Moderate Plus Profile Sterile, 515cc
• 00081317008866: Low Height, Moderate Plus Profile Sterile, 465cc
• 00081317008859: Low Height, Moderate Plus Profile Sterile, 415cc
• 00081317008842: Low Height, Moderate Plus Profile Sterile, 370cc
• 00081317008835: Low Height, Moderate Plus Profile Sterile, 330cc
• 00081317008828: Low Height, Moderate Plus Profile Sterile, 290cc
• 00081317008811: Low Height, Moderate Plus Profile Sterile, 255cc
• 00081317008804: Low Height, Moderate Plus Profile Sterile, 225cc
• 00081317008798: Low Height, Moderate Plus Profile Sterile, 195cc
• 00081317008781: Low Height, Moderate Plus Profile Sterile, 170cc
• 00081317008774: Low Height, Moderate Plus Profile Sterile, 145cc
• 00081317008767: Low Height, Moderate Plus Profile Sterile, 125cc