Catalog Number

-

Brand Name

Klarity Medical

Version/Model Number

RG461-5SHT

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

Yes

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

K022708

Product Code

IYE

Product Code Name

Accelerator, Linear, Medical

Public Device Record Key

cdd44350-bed2-42d3-a549-c4d4bb3c6cce

Public Version Date

September 16, 2020

Public Version Number

4

DI Record Publish Date

July 26, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-