Catalog Number

MTHF016

Brand Name

Nasion Cushion

Version/Model Number

MTHF016

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

K132908,K132908

Product Code

IYE

Product Code Name

Accelerator, linear, medical

Public Device Record Key

4038030f-caef-4fa3-bab5-1fba0b5d000e

Public Version Date

April 01, 2020

Public Version Number

8

DI Record Publish Date

August 02, 2017

Package DI Number

00841439104224

Quantity per Package

12

Contains DI Package

10841439104221

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-