Catalog Number

-

Brand Name

Clarity®

Version/Model Number

9100-00062

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Unsafe

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

K141855

Product Code

IWB

Product Code Name

System, radiation therapy, radionuclide

Public Device Record Key

fc5f89e7-dfad-4f39-8b74-c34c32b9b6e0

Public Version Date

April 04, 2019

Public Version Number

1

DI Record Publish Date

March 27, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-