Catalog Number

PSI-8F-11/D

Brand Name

Prelude®

Version/Model Number

10884450614713

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

8e30ff84-c9fe-412f-aea0-29dfdcf3f5cd

Public Version Date

January 21, 2022

Public Version Number

1

DI Record Publish Date

January 13, 2022

Package DI Number

20884450614710

Quantity per Package

4

Contains DI Package

10884450614713

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-