Catalog Number

301001

Brand Name

Positioning Cushion

Version/Model Number

301001

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

August 30, 2019

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

K060737,K093738

Product Code

IYE

Product Code Name

Accelerator, linear, medical

Public Device Record Key

e2c795c0-6dcf-4fd3-a131-31d987f75df9

Public Version Date

August 30, 2019

Public Version Number

6

DI Record Publish Date

August 02, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-