Catalog Number

-

Brand Name

Mask TSS-HO

Version/Model Number

TSS-HOPc

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

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K142420,K142420

Product Code

IYE

Product Code Name

Accelerator, linear, medical

Public Device Record Key

4eefca93-d5b4-4e46-bfdf-c7bfa1602d87

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

March 23, 2017

Package DI Number

08719425707013

Quantity per Package

10

Contains DI Package

08719425707624

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-