Catalog Number

RSZ-SMHX-400S

Brand Name

MENTOR MemoryGel Xtra Resterilizable Gel Sizer

Version/Model Number

RSZSMHX400S

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

Yes

For Single-Use

-

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K062421

Product Code

MRD

Product Code Name

SIZER, MAMMARY, BREAST IMPLANT VOLUME

Public Device Record Key

30f658bd-a18c-404c-b7ce-c5f4af9c848d

Public Version Date

February 09, 2021

Public Version Number

1

DI Record Publish Date

February 01, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-