Catalog Number

TSX-545

Brand Name

Natrelle Inspira SoftTouch Breast Implants

Version/Model Number

TSX-545

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

P020056

Product Code

FTR

Product Code Name

Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled

Public Device Record Key

fd603881-1999-4303-a628-50d5c6ad8595

Public Version Date

October 15, 2021

Public Version Number

4

DI Record Publish Date

January 13, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-