Catalog Number

468-380

Brand Name

NATRELLE Saline-Filled Breast Implants

Version/Model Number

468-380

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

July 24, 2019

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

a2058666-a6c9-4cf3-ab16-04afc6898d77

Public Version Date

October 13, 2021

Public Version Number

5

DI Record Publish Date

September 17, 2014

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-