Catalog Number

350-4303M

Brand Name

MENTOR Tissue Expander

Version/Model Number

3504303M

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"

-

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

K842883

Product Code

LCJ

Product Code Name

EXPANDER, SKIN, INFLATABLE

Public Device Record Key

7472fb3c-ee6e-4a08-9390-1780cde3f69d

Public Version Date

February 11, 2021

Public Version Number

5

DI Record Publish Date

September 14, 2015

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-