Catalog Number

P301008

Brand Name

Pro Advantage

Version/Model Number

P301008

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

-

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K955246,K955246

Product Code

ITX

Product Code Name

Transducer, Ultrasonic, Diagnostic

Public Device Record Key

49b57963-bd5c-4b75-82cb-04daa059e144

Public Version Date

June 10, 2022

Public Version Number

4

DI Record Publish Date

February 13, 2017

Package DI Number

M220P3010083

Quantity per Package

12

Contains DI Package

M220P3010088

Package Discontinue Date

-

Package Status

-

Package Type

Case