Catalog Number

68HP-700

Brand Name

NATRELLE Saline-Filled Breast Implants

Version/Model Number

68HP-700

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Safe

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

P990074

Product Code

FWM

Product Code Name

Prosthesis, Breast, Inflatable, Internal, Saline

Public Device Record Key

bf191d34-43ce-4a66-bd79-1006d770b156

Public Version Date

April 30, 2021

Public Version Number

4

DI Record Publish Date

September 17, 2014

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-