Catalog Number

350-9115

Brand Name

Mentor CPX4 with suture tabs, low height, smooth

Version/Model Number

3509115

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

K182335

Product Code

LCJ

Product Code Name

EXPANDER, SKIN, INFLATABLE

Public Device Record Key

b69a5df7-6a3e-43b2-8755-d3b48c48a61a

Public Version Date

February 11, 2021

Public Version Number

3

DI Record Publish Date

November 13, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-