Catalog Number

-

Brand Name

GREEN CROSS

Version/Model Number

GFM12

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

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"

-

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

K123787

Product Code

FXX

Product Code Name

Mask, Surgical

Public Device Record Key

0087e042-27cd-423f-a1ee-66fff750ce90

Public Version Date

January 04, 2021

Public Version Number

2

DI Record Publish Date

July 12, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-