Catalog Number

K20T-00035

Brand Name

Merit Medical®

Version/Model Number

00884450551974

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

9a2c7af7-76a5-41b3-9d51-8dd8b1ccba36

Public Version Date

February 15, 2021

Public Version Number

1

DI Record Publish Date

February 05, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-