Catalog Number

-

Brand Name

Klarity Medical

Version/Model Number

R550-U

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Safe

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K132124

Product Code

IYE

Product Code Name

Accelerator, Linear, Medical

Public Device Record Key

b607f612-b8c2-4d0e-9ea3-9222480cc00a

Public Version Date

September 16, 2020

Public Version Number

5

DI Record Publish Date

June 27, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-