Catalog Number

-

Brand Name

5P1 Transducer

Version/Model Number

11014154

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

-

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K180039,K201130

Product Code

ITX

Product Code Name

Transducer, ultrasonic, diagnostic

Public Device Record Key

f1dca1ff-33fc-4d71-a694-6748c9c07b5c

Public Version Date

November 18, 2021

Public Version Number

8

DI Record Publish Date

February 20, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-