Catalog Number

PHR6F11018SS/F

Brand Name

Prelude EASE™

Version/Model Number

10884450526122

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

63b2f962-f6b4-4949-8c93-59b26ebe75af

Public Version Date

October 31, 2022

Public Version Number

1

DI Record Publish Date

October 21, 2022

Package DI Number

20884450526129

Quantity per Package

4

Contains DI Package

10884450526122

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-