Catalog Number

-

Brand Name

TravelKit contains First Step Kit and Soiled Scope Bag

Version/Model Number

TK200

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

cfccb3bd-544b-4e85-bbb7-a09cda4c007d

Public Version Date

March 21, 2022

Public Version Number

2

DI Record Publish Date

September 24, 2020

Package DI Number

10843356100904

Quantity per Package

50

Contains DI Package

00843356100907

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-