Catalog Number

PSI-8F-23-035MT/D

Brand Name

Prelude®

Version/Model Number

10884450614744

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

DRE

Product Code Name

DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION

Public Device Record Key

eeb42943-2380-466a-9db0-51afa611fc89

Public Version Date

April 29, 2022

Public Version Number

1

DI Record Publish Date

April 21, 2022

Package DI Number

20884450614741

Quantity per Package

4

Contains DI Package

10884450614744

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-