Catalog Number

CLI-228-06

Brand Name

Elite HV® R Hydrophilic Introducer Kit

Version/Model Number

CLI-228-06

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

d57ca76e-5004-4e74-ae99-09fde96f06d3

Public Version Date

December 21, 2020

Public Version Number

1

DI Record Publish Date

December 11, 2020

Package DI Number

10841268109299

Quantity per Package

5

Contains DI Package

00841268109292

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Shelf Box