Catalog Number

-

Brand Name

Mask REMCF-4

Version/Model Number

REMCF-4Pc

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

05d49fc2-4fad-4515-9177-0cb5073059a2

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

March 23, 2017

Package DI Number

08719425701530

Quantity per Package

10

Contains DI Package

08719425706900

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-