Catalog Number

551222

Brand Name

COE FOAM™ II

Version/Model Number

551222

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

September 14, 2021

Issuing Agency

In HIBCC

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

-

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

-

Product Code

LRJ

Product Code Name

Disinfectant, medical devices

Public Device Record Key

aafd32ec-6eba-4c93-9b1e-16d85cec8b70

Public Version Date

September 15, 2021

Public Version Number

3

DI Record Publish Date

February 10, 2017

Package DI Number

D6585512222

Quantity per Package

12

Contains DI Package

D6585512221

Package Discontinue Date

July 28, 2020

Package Status

Not in Commercial Distribution

Package Type

-