Catalog Number

-

Brand Name

Custom Procedure Kit

Version/Model Number

4005047

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

b1eb2f26-357f-48df-9e18-1f2f443238d5

Public Version Date

April 27, 2022

Public Version Number

3

DI Record Publish Date

February 18, 2022

Package DI Number

40677964027336

Quantity per Package

12

Contains DI Package

40677964027329

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-