Catalog Number

-

Brand Name

PremierPro

Version/Model Number

3400

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"

Yes

For Single-Use

Yes

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

K101952,K101952,K101952

Product Code

ITX

Product Code Name

Transducer, Ultrasonic, Diagnostic

Public Device Record Key

177c8691-9d7f-4faa-a3b0-9acfbb68d9df

Public Version Date

June 10, 2022

Public Version Number

4

DI Record Publish Date

June 01, 2016

Package DI Number

20818566012801

Quantity per Package

16

Contains DI Package

10818566012804

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case