Catalog Number

CLI-124-17

Brand Name

Elite HV Transitionless Hemostasis Valve Introducer Kit

Version/Model Number

CLI-124-17

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

K043525,K043525,K043525

Product Code

DYB

Product Code Name

Introducer, Catheter

Public Device Record Key

35490d64-c2d9-44c8-8fd6-5de55a888ad4

Public Version Date

December 14, 2020

Public Version Number

1

DI Record Publish Date

December 04, 2020

Package DI Number

10841268109022

Quantity per Package

10

Contains DI Package

00841268109025

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Shelf Box