Catalog Number

117110

Brand Name

MaxSupport™ 1

Version/Model Number

HS1

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Safe

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

K142420

Product Code

IYE

Product Code Name

Accelerator, Linear, Medical

Public Device Record Key

b94271fb-de9d-4668-b3d9-eabb8d6ae6ec

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

December 31, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-