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,K961029

Product Code

IYO

Product Code Name

System, imaging, pulsed echo, ultrasonic

Public Device Record Key

70c79a10-fdb1-4695-92c8-9e3c78557dc5

Public Version Date

July 06, 2018

Public Version Number

4

DI Record Publish Date

March 08, 2017

Package DI Number

30748426053958

Quantity per Package

25

Contains DI Package

00748426053957

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-