Catalog Number

PG7F90SX

Brand Name

Prelude Roadster™

Version/Model Number

00884450532553

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

GBX

Product Code Name

CATHETER, IRRIGATION

Public Device Record Key

3de0877d-5b52-4bc0-96a1-30a48ce33117

Public Version Date

August 31, 2022

Public Version Number

1

DI Record Publish Date

August 23, 2022

Package DI Number

10884450532550

Quantity per Package

5

Contains DI Package

00884450532553

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-