Catalog Number

-

Brand Name

Freudenberg

Version/Model Number

FPMD2020

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"

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

K210063,K210063,K210063

Product Code

FXX

Product Code Name

Mask, Surgical

Public Device Record Key

80b8b4ea-c812-440e-b0de-bb926ba3136f

Public Version Date

May 18, 2021

Public Version Number

1

DI Record Publish Date

May 10, 2021

Package DI Number

20850024185009

Quantity per Package

20

Contains DI Package

10850024185002

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Shipper Box