Catalog Number

-

Brand Name

Single-Use First Step Enzymatic Spray

Version/Model Number

ED-P2

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)

-

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

b6e896da-a12d-43a7-a3a9-5135c197d831

Public Version Date

October 02, 2020

Public Version Number

1

DI Record Publish Date

September 24, 2020

Package DI Number

10843356101857

Quantity per Package

48

Contains DI Package

00843356101850

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-