MENTOR MemoryShape TM Plus Resterilizable Gel Sizer RSZ1109S

GUDID 00081317008941

Tall Height, Moderate Plus Profile Sterile, 270cc

MENTOR TEXAS L.P.

Invasive breast implant sizer, reusable

• Primary Device ID: 00081317008941
• NIH Device Record Key: 37f6f74e-eb99-4e23-958e-914c291d2d9e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MENTOR MemoryShape TM Plus Resterilizable Gel Sizer
• Version Model Number: RSZ1109S
• Catalog Number: RSZ1109S
• 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	00081317008941 [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

[00081317008941]

Moist Heat or Steam Sterilization

[00081317008941]

Moist Heat or Steam Sterilization

[00081317008941]

Moist Heat or Steam Sterilization

[00081317008941]

Moist Heat or Steam Sterilization

[00081317008941]

Moist Heat or Steam Sterilization

[00081317008941]

Moist Heat or Steam Sterilization

[00081317008941]

Moist Heat or Steam Sterilization

[00081317008941]

Moist Heat or Steam Sterilization

[00081317008941]

Moist Heat or Steam Sterilization

[00081317008941]

Moist Heat or Steam Sterilization

[00081317008941]

Moist Heat or Steam Sterilization

[00081317008941]

Moist Heat or Steam Sterilization

[00081317008941]

Moist Heat or Steam Sterilization

[00081317008941]

Moist Heat or Steam Sterilization

[00081317008941]

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 TM Plus Resterilizable Gel Sizer]

• 00081317009023: Tall Height, Moderate Plus Profile Sterile, 680cc
• 00081317009016: Tall Height, Moderate Plus Profile Sterile, 615cc
• 00081317009009: Tall Height, Moderate Plus Profile Sterile, 555cc
• 00081317008996: Tall Height, Moderate Plus Profile Sterile, 495cc
• 00081317008989: Tall Height, Moderate Plus Profile Sterile, 445cc
• 00081317008972: Tall Height, Moderate Plus Profile Sterile, 395cc
• 00081317008965: Tall Height, Moderate Plus Profile Sterile, 350cc
• 00081317008958: Tall Height, Moderate Plus Profile Sterile, 305cc
• 00081317008941: Tall Height, Moderate Plus Profile Sterile, 270cc
• 00081317008934: Tall Height, Moderate Plus Profile Sterile, 235cc
• 00081317008927: Tall Height, Moderate Plus Profile Sterile, 205cc
• 00081317008910: Tall Height, Moderate Plus Profile Sterile, 175cc
• 00081317008903: Tall Height, Moderate Plus Profile Sterile, 145cc