Catalog Number

-

Brand Name

MICROTEK

Version/Model Number

1

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)

Yes

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

K961029,K961029,K961029

Product Code

IYO

Product Code Name

System, imaging, pulsed echo, ultrasonic

Public Device Record Key

094b9749-7676-4855-9f63-0ac57fbe6560

Public Version Date

March 22, 2022

Public Version Number

5

DI Record Publish Date

January 30, 2017

Package DI Number

30748426053767

Quantity per Package

25

Contains DI Package

00748426054008

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-