Catalog Number

-

Brand Name

KLARITY MEDICAL

Version/Model Number

R7540-30C

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Conditional

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

K132124

Product Code

IYE

Product Code Name

Accelerator, Linear, Medical

Public Device Record Key

7521f2ce-1dd0-4ddd-8617-7d28e1724f33

Public Version Date

June 16, 2022

Public Version Number

1

DI Record Publish Date

June 08, 2022

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-