Catalog Number

-

Brand Name

First Step Bedside Kit - Stand-Up Pouch, Gemini Cleaning Pad

Version/Model Number

EP-4G

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

59e13a05-488d-49ad-831d-215d19079e9a

Public Version Date

July 08, 2021

Public Version Number

2

DI Record Publish Date

September 24, 2020

Package DI Number

10843356100287

Quantity per Package

35

Contains DI Package

00843356100280

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-