Catalog Number

SMXP100RH

Brand Name

ARTOURA Breast Tissue Expander

Version/Model Number

SMXP100RH

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Unsafe

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

K161176

Product Code

LCJ

Product Code Name

EXPANDER, SKIN, INFLATABLE

Public Device Record Key

1d383e81-5694-4f59-8ea7-103b43d5d530

Public Version Date

September 23, 2019

Public Version Number

4

DI Record Publish Date

July 01, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-