Catalog Number

-

Brand Name

Single-Use First Step Enzymatic Spray

Version/Model Number

ED-P8

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

February 04, 2022

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

MNL

Product Code Name

Accessories, Cleaning Brushes, For Endoscope

Public Device Record Key

a9f1a888-9d9b-47bb-ae52-ef627c797945

Public Version Date

February 07, 2022

Public Version Number

2

DI Record Publish Date

September 24, 2020

Package DI Number

10843356101864

Quantity per Package

12

Contains DI Package

00843356101867

Package Discontinue Date

February 04, 2022

Package Status

Not in Commercial Distribution

Package Type

-