Catalog Number

497818

Brand Name

Percutaneous Micro-Introducer Kit

Version/Model Number

497818

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

8b87f247-0e0a-46fd-b7d3-f54ca2749090

Public Version Date

June 07, 2019

Public Version Number

3

DI Record Publish Date

September 20, 2016

Package DI Number

10886333215079

Quantity per Package

10

Contains DI Package

00886333215072

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box