Catalog Number

SHPB-200

Brand Name

MENTOR MemoryGel BOOST Breast Implant

Version/Model Number

SHPB200

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

-

Product Code

FTR

Product Code Name

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

Public Device Record Key

f4f364bf-c194-4d3b-8a1a-b6977a664fb3

Public Version Date

August 16, 2022

Public Version Number

2

DI Record Publish Date

February 15, 2022

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-