Catalog Number

A240-1404

Brand Name

IMAGE DIAGNOSTICS, INC.

Version/Model Number

1000F-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)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

BWN

Product Code Name

Table And Attachments, Operating-Room

Public Device Record Key

5b3e940c-7617-4d0f-8ffe-8745d577587e

Public Version Date

October 24, 2022

Public Version Number

3

DI Record Publish Date

September 18, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-