Catalog Number

K20T-00021

Brand Name

Merit Medical®

Version/Model Number

00884450310304

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

NWU

Product Code Name

Endoscope introducer kit

Public Device Record Key

4130125c-818c-41f8-8c9a-beb74d9ca0c5

Public Version Date

October 23, 2019

Public Version Number

2

DI Record Publish Date

March 21, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-