IlluminatusDXA Software - Norland at Swissray

Duns Number:110329096

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More Product Details

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

Product Characteristics

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 Details

Product Code

KGI

Product Code Name

Densitometer, Bone

Device Record Status

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

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"NORLAND AT SWISSRAY" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 13