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MENTOR MemoryGel Xtra Resterilizable Gel Sizer

FDA UDI

Class U (US FDA UDI)

by Mentor Texas LP

Identity

Trade Name
MENTOR MemoryGel Xtra Resterilizable Gel Sizer FDA UDI
Generic Name
Invasive breast implant sizer, fixed, reusable FDA UDI
Device Name
High Profile Xtra, Gel Sizer For Use With SHPX-595 FDA UDI
Model / Reference
RSZSHPX595S FDA UDI
Description
High Profile Xtra, Gel Sizer For Use With SHPX-595 FDA UDI

Identifiers

Catalog Number
RSZ-SHPX-595S FDA UDI
Primary DI / UDI-DI
00081317026310 FDA UDI
510(k) Number
K062421 FDA UDI
FDA Product Code
MRD FDA UDI
GMDN Term
Invasive breast implant sizer, fixed, reusable FDA UDI

Classification

Device Class
U FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Invasive breast implant sizer, fixed, reusable

MENTOR MemoryGel Xtra Resterilizable Gel Sizer by Mentor Texas LP — Class U — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Invasive breast implant sizer, fixed, reusable.

Cleared under the same submission

K062421 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Mentor Texas LP

Sources (1)

  • FDA UDI 7137f24a-5d8e-40a0-9fd8-6af7de0b276d 36 fields · synced May 30, 2026