Catalog Number

OM-9000Z

Brand Name

Acrobat SUV Stabilizer

Version/Model Number

OM-9000Z

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

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

-

Product Code

MWS

Product Code Name

Stabilizer,Heart

Public Device Record Key

598d2ae4-b553-479e-aea9-b4caa3ee8fea

Public Version Date

April 09, 2021

Public Version Number

2

DI Record Publish Date

April 27, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-