Catalog Number

-

Brand Name

SUPERFIT

Version/Model Number

FMK-50

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

K123115,K123115,K123115

Product Code

FXX

Product Code Name

Mask, Surgical

Public Device Record Key

9e5d994f-4a84-461a-839e-8256bf03f54e

Public Version Date

August 14, 2020

Public Version Number

1

DI Record Publish Date

August 06, 2020

Package DI Number

10814639024972

Quantity per Package

50

Contains DI Package

00814639024975

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box