Catalog Number

-

Brand Name

ACIST HDi® Cart

Version/Model Number

017991

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

K193183,K193183

Product Code

IYO

Product Code Name

System, Imaging, Pulsed Echo, Ultrasonic

Public Device Record Key

875fd422-8e4f-40a9-ba94-dac043acf082

Public Version Date

May 20, 2020

Public Version Number

1

DI Record Publish Date

May 12, 2020

Package DI Number

30841716102647

Quantity per Package

1

Contains DI Package

10841716102643

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-