Catalog Number

KIT-069-05

Brand Name

Micro-Introducer Kit

Version/Model Number

KIT-069-05

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

December 15, 2020

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

9be39921-e131-4e05-83b8-f694355c6fa2

Public Version Date

December 16, 2020

Public Version Number

4

DI Record Publish Date

March 21, 2017

Package DI Number

20841268107193

Quantity per Package

100

Contains DI Package

10841268107196

Package Discontinue Date

December 15, 2020

Package Status

Not in Commercial Distribution

Package Type

Shipper Box