Catalog Number

CEK-1807

Brand Name

Compliance EndoKit™

Version/Model Number

CEK-1807

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)

Yes

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

d2eda7ca-1ef4-4db2-adcc-d54b95b06026

Public Version Date

September 22, 2022

Public Version Number

1

DI Record Publish Date

September 14, 2022

Package DI Number

00191506034665

Quantity per Package

20

Contains DI Package

00191506034658

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-