Catalog Number

682084/A

Brand Name

P23XL™

Version/Model Number

10884450323189

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

DXO

Product Code Name

TRANSDUCER, PRESSURE, CATHETER TIP

Public Device Record Key

fbdef20c-ee5b-4a10-a973-abc2324b6def

Public Version Date

December 13, 2021

Public Version Number

2

DI Record Publish Date

November 27, 2018

Package DI Number

20884450323186

Quantity per Package

10

Contains DI Package

10884450323189

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-