Catalog Number

-

Brand Name

IlluminatusDXA Software

Version/Model Number

4

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

K091325

Product Code

KGI

Product Code Name

Densitometer, Bone

Public Device Record Key

62f77351-842e-4440-875a-cb293387b4ca

Public Version Date

August 04, 2020

Public Version Number

1

DI Record Publish Date

July 27, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-