Catalog Number

-

Brand Name

Frame Assembly

Version/Model Number

60-110

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K103616,K991546

Product Code

IYE

Product Code Name

Accelerator, Linear, Medical

Public Device Record Key

63459ded-a9fe-47b1-8013-921558ea401b

Public Version Date

May 31, 2021

Public Version Number

1

DI Record Publish Date

May 21, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-