MENTOR MemoryGel Xtra Resterilizable Gel Sizer - MemoryGel Xtra Moderate High (MHX) Smooth Sizer - MENTOR TEXAS L.P.

Duns Number:167450993

Device Description: MemoryGel Xtra Moderate High (MHX) Smooth Sizer 150cc

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More Product Details

Catalog Number

RSZ-SMHX-150S

Brand Name

MENTOR MemoryGel Xtra Resterilizable Gel Sizer

Version/Model Number

RSZSMHX150S

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

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 Details

Product Code

MRD

Product Code Name

SIZER, MAMMARY, BREAST IMPLANT VOLUME

Device Record Status

Public Device Record Key

43082ca6-d70d-437e-a890-53ceb1f04416

Public Version Date

February 09, 2021

Public Version Number

1

DI Record Publish Date

February 01, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"MENTOR TEXAS L.P." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 17
2 A medical device with a moderate to high risk that requires special controls. 128
3 A medical device with high risk that requires premarket approval 545
U Unclassified 514