Catalog Number

-

Brand Name

Clarity®

Version/Model Number

9310-00043

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

K141855

Product Code

IWB

Product Code Name

System, radiation therapy, radionuclide

Public Device Record Key

314ac809-7753-44a6-acf6-8d167b64e0a6

Public Version Date

December 20, 2018

Public Version Number

1

DI Record Publish Date

November 19, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-