Catalog Number

334-1254

Brand Name

MENTOR MemoryShape Breast Implant

Version/Model Number

3341254

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

Yes

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

P060028

Product Code

FTR

Product Code Name

Prosthesis, breast, noninflatable, internal, silicone gel-filled

Public Device Record Key

8817193a-7f16-4b90-b13a-8dcbb8201a2b

Public Version Date

February 11, 2021

Public Version Number

3

DI Record Publish Date

February 28, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-