Catalog Number

-

Brand Name

Lunar iDXA

Version/Model Number

F1

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K052581,K133664,K161682,K191112

Product Code

KGI

Product Code Name

Densitometer, bone

Public Device Record Key

02960696-3f38-4059-8b5e-3583ac8b3e2e

Public Version Date

November 28, 2019

Public Version Number

5

DI Record Publish Date

June 27, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-