Catalog Number

CLI-224-055

Brand Name

Vascular Access Introducer Set

Version/Model Number

CLI-224-055

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

524cf990-e3c5-434b-9945-6290fabdfa5a

Public Version Date

June 07, 2019

Public Version Number

3

DI Record Publish Date

February 06, 2018

Package DI Number

20841268107308

Quantity per Package

50

Contains DI Package

10841268107301

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Shipper Box