Catalog Number

PHR5F7018SC/F

Brand Name

Prelude EASE™

Version/Model Number

10884450526092

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

DYB

Product Code Name

Introducer, catheter

Public Device Record Key

0a730f3a-3b58-4192-9660-5b53b923f1a2

Public Version Date

September 26, 2022

Public Version Number

1

DI Record Publish Date

September 16, 2022

Package DI Number

20884450526099

Quantity per Package

4

Contains DI Package

10884450526092

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-