Catalog Number

NA

Brand Name

Delivery Analysis

Version/Model Number

1062213

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

K143269

Product Code

IYE

Product Code Name

Accelerator, Linear, Medical

Public Device Record Key

5fa6bfa4-885c-4acd-8b7d-e3c0d5557961

Public Version Date

February 19, 2020

Public Version Number

1

DI Record Publish Date

February 11, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-