MENTOR MemoryShape MM Plus Resterilizable Gel Sizer RSZ1305S

GUDID 00081317008590

Medium Height, Moderate Plus Profile Sterile, 420cc

MENTOR TEXAS L.P.

Invasive breast implant sizer, reusable

• Primary Device ID: 00081317008590
• NIH Device Record Key: e9278a98-5f03-46fd-b57f-6904588f2dc7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MENTOR MemoryShape MM Plus Resterilizable Gel Sizer
• Version Model Number: RSZ1305S
• Catalog Number: RSZ1305S
• 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	00081317008590 [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

[00081317008590]

Moist Heat or Steam Sterilization

[00081317008590]

Moist Heat or Steam Sterilization

[00081317008590]

Moist Heat or Steam Sterilization

[00081317008590]

Moist Heat or Steam Sterilization

[00081317008590]

Moist Heat or Steam Sterilization

[00081317008590]

Moist Heat or Steam Sterilization

[00081317008590]

Moist Heat or Steam Sterilization

[00081317008590]

Moist Heat or Steam Sterilization

[00081317008590]

Moist Heat or Steam Sterilization

[00081317008590]

Moist Heat or Steam Sterilization

[00081317008590]

Moist Heat or Steam Sterilization

[00081317008590]

Moist Heat or Steam Sterilization

[00081317008590]

Moist Heat or Steam Sterilization

[00081317008590]

Moist Heat or Steam Sterilization

[00081317008590]

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 MM Plus Resterilizable Gel Sizer]

• 00081317008637: Medium Height, Moderate Plus Profile Sterile, 650cc
• 00081317008620: Medium Height, Moderate Plus Profile Sterile, 585cc
• 00081317008613: Medium Height, Moderate Plus Profile Sterile, 525cc
• 00081317008606: Medium Height, Moderate Plus Profile Sterile, 475cc
• 00081317008590: Medium Height, Moderate Plus Profile Sterile, 420cc
• 00081317008583: Medium Height, Moderate Plus Profile Sterile, 375cc
• 00081317008576: Medium Height, Moderate Plus Profile Sterile, 330cc
• 00081317008569: Medium Height, Moderate Plus Profile Sterile, 295cc
• 00081317008552: Medium Height, Moderate Plus Profile Sterile, 255cc
• 00081317008545: Medium Height, Moderate Plus Profile Sterile, 225cc
• 00081317008538: Medium Height, Moderate Plus Profile Sterile, 195cc
• 00081317008521: Medium Height, Moderate Plus Profile Sterile, 165cc
• 00081317008514: Medium Height, Moderate Plus Profile Sterile, 140cc