Catalog Number

-

Brand Name

LessRay

Version/Model Number

8230045

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

K173314

Product Code

JAA

Product Code Name

System, x-ray, fluoroscopic, image-intensified

Public Device Record Key

67357e05-a631-47f8-97a7-7e1fc97d2725

Public Version Date

June 23, 2021

Public Version Number

1

DI Record Publish Date

June 15, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-