Catalog Number

-

Brand Name

Thermoplastic

Version/Model Number

1

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

Yes

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

K122888,K122888

Product Code

IYE

Product Code Name

Accelerator, Linear, Medical

Public Device Record Key

00c978da-2c1e-456d-a571-1ab9e0e5efe2

Public Version Date

January 08, 2020

Public Version Number

1

DI Record Publish Date

December 31, 2019

Package DI Number

10628341930229

Quantity per Package

5

Contains DI Package

00628341930222

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-