Catalog Number

F004.0119

Brand Name

ACURA Stabilization System - Ball Tip Probe

Version/Model Number

F004.0119

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

HXB

Product Code Name

Probe

Public Device Record Key

de219117-4d63-449a-ae98-91a2cde354b0

Public Version Date

March 29, 2022

Public Version Number

1

DI Record Publish Date

March 21, 2022

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-