Catalog Number

-

Brand Name

EmPower

Version/Model Number

10-4100

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

-

Prescription Use (Rx)

-

Over the Counter (OTC)

Yes

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

f9f4bce3-52e0-4bb3-a9eb-37927fb8eac8

Public Version Date

October 28, 2022

Public Version Number

3

DI Record Publish Date

August 31, 2016

Package DI Number

10615375005559

Quantity per Package

4

Contains DI Package

00615375005552

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE