MENTOR MemoryShape MM Resterilizable Gel Sizer RSZ0958S

GUDID 00081317008378

Medium Height, Moderate Profile Sterile, 135cc

MENTOR TEXAS L.P.

Invasive breast implant sizer, reusable

• Primary Device ID: 00081317008378
• NIH Device Record Key: 661f94b4-a8b9-424b-94bb-c62f107ab476
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MENTOR MemoryShape MM Resterilizable Gel Sizer
• Version Model Number: RSZ0958S
• Catalog Number: RSZ0958S
• 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	00081317008378 [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

[00081317008378]

Moist Heat or Steam Sterilization

[00081317008378]

Moist Heat or Steam Sterilization

[00081317008378]

Moist Heat or Steam Sterilization

[00081317008378]

Moist Heat or Steam Sterilization

[00081317008378]

Moist Heat or Steam Sterilization

[00081317008378]

Moist Heat or Steam Sterilization

[00081317008378]

Moist Heat or Steam Sterilization

[00081317008378]

Moist Heat or Steam Sterilization

[00081317008378]

Moist Heat or Steam Sterilization

[00081317008378]

Moist Heat or Steam Sterilization

[00081317008378]

Moist Heat or Steam Sterilization

[00081317008378]

Moist Heat or Steam Sterilization

[00081317008378]

Moist Heat or Steam Sterilization

[00081317008378]

Moist Heat or Steam Sterilization

[00081317008378]

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

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• 00081317008422: Medium Height, Moderate Profile Sterile, 280cc
• 00081317008415: Medium Height, Moderate Profile Sterile, 245cc
• 00081317008408: Medium Height, Moderate Profile Sterile, 215cc
• 00081317008392: Medium Height, Moderate Profile Sterile, 180cc
• 00081317008385: Medium Height, Moderate Profile Sterile, 155cc
• 00081317008378: Medium Height, Moderate Profile Sterile, 135cc
• 00081317008361: Medium Height, Moderate Profile Sterile, 120cc