Catalog Number

S-MAK501NBT/A

Brand Name

Merit S-MAK™

Version/Model Number

00884450144442

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

DRE

Product Code Name

DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION

Public Device Record Key

94a50a1c-a2f2-41f2-af78-1f99924d9cd5

Public Version Date

October 11, 2021

Public Version Number

4

DI Record Publish Date

September 24, 2016

Package DI Number

10884450144449

Quantity per Package

10

Contains DI Package

00884450144442

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-