Catalog Number

557202

Brand Name

COE®

Version/Model Number

557202

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

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

-

Product Code

LRJ

Product Code Name

Disinfectant, medical devices

Public Device Record Key

8bda02ec-5eac-4a46-a54d-7e1f69edced4

Public Version Date

September 15, 2021

Public Version Number

3

DI Record Publish Date

February 10, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-