Catalog Number

-

Brand Name

FORA

Version/Model Number

ASTM-L3

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

K201549,K201549

Product Code

FXX

Product Code Name

Mask, Surgical

Public Device Record Key

4cba9c2c-d9a3-4286-a45b-56eaa2f9e0c6

Public Version Date

November 22, 2021

Public Version Number

1

DI Record Publish Date

November 12, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-