Catalog Number

-

Brand Name

Accuro

Version/Model Number

00001

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

K132736,K132736

Product Code

ITX

Product Code Name

Transducer, Ultrasonic, Diagnostic

Public Device Record Key

442c1315-02c1-47e0-bf3a-12620f4c2eb3

Public Version Date

December 21, 2018

Public Version Number

5

DI Record Publish Date

July 22, 2016

Package DI Number

B015000011

Quantity per Package

1

Contains DI Package

B015000010

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-