Catalog Number

PHR5F11021SSC/F

Brand Name

Prelude EASE™

Version/Model Number

10884450525996

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

d5f9febb-8b18-4fff-8eb4-5de5b114eed5

Public Version Date

October 11, 2021

Public Version Number

2

DI Record Publish Date

June 14, 2021

Package DI Number

20884450525993

Quantity per Package

4

Contains DI Package

10884450525996

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-