Catalog Number

-

Brand Name

Clarity®

Version/Model Number

1531854

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

June 22, 2017

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K141855

Product Code

IYE

Product Code Name

Accelerator, linear, medical

Public Device Record Key

ae7c4403-93d1-471b-8bce-391f9d4f4062

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

June 22, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-