Catalog Number

2

Brand Name

FUJIYAMA

Version/Model Number

12011

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

September 30, 2021

Issuing Agency

In GS1

MRI safety Status

Labeling does not contain MRI Safety Information

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"

Yes

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

-

Product Code

FXX

Product Code Name

Mask, Surgical

Public Device Record Key

4b0e09d8-73ca-471c-9fac-d91c5ecd2d91

Public Version Date

September 30, 2021

Public Version Number

2

DI Record Publish Date

August 16, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-