LODOX - The Xmplar-dr is a full body, low dose, X-ray - LODOX SYSTEMS (PTY) LTD

Duns Number:635684694

Device Description: The Xmplar-dr is a full body, low dose, X-ray scanner which produce digital X-ray images u The Xmplar-dr is a full body, low dose, X-ray scanner which produce digital X-ray images used for diagnostic purposes in both trauma and general radiology cases as well as in forensic pathology cases.

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More Product Details

Catalog Number

CL-08-0013-H2

Brand Name

LODOX

Version/Model Number

eXero-dr

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K013999

Product Code Details

Product Code

JAK

Product Code Name

System, X-Ray, Tomography, Computed

Device Record Status

Public Device Record Key

6cc32fb2-c2b4-4237-8a8a-514665c7ccec

Public Version Date

August 20, 2021

Public Version Number

1

DI Record Publish Date

August 12, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"LODOX SYSTEMS (PTY) LTD" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 11