Catalog Number

MPK-4F

Brand Name

ClosureFast

Version/Model Number

MPK-4F

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

OFL

Product Code Name

Percutaneous sheath introducer kit

Public Device Record Key

f7c56872-a2b8-4595-b9d6-4d25fed8d1eb

Public Version Date

June 17, 2022

Public Version Number

3

DI Record Publish Date

May 24, 2017

Package DI Number

20884521140377

Quantity per Package

100

Contains DI Package

10884521140370

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

PACK_OR_INNER_PACK