Catalog Number

KIT-076-02

Brand Name

Stiffen Micro-Introducer Kit

Version/Model Number

KIT-076-02

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"

Yes

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

7221735a-b4d7-4eac-aa43-6b80221ea3d1

Public Version Date

April 27, 2022

Public Version Number

1

DI Record Publish Date

April 19, 2022

Package DI Number

10841268109794

Quantity per Package

10

Contains DI Package

00841268109797

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Shelf Box