Catalog Number

A100-2244

Brand Name

IMAGE DIAGNOSTICS, INC.

Version/Model Number

LOW-PROFILE VAB

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

NOD

Product Code Name

Board, Arm (Wtih Cover), Non-Sterile

Public Device Record Key

0cca1b87-05ca-4a09-ac1b-5e57a4c5e187

Public Version Date

October 19, 2018

Public Version Number

2

DI Record Publish Date

July 09, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-