Catalog Number

410MW

Brand Name

Hedy SofMask

Version/Model Number

410MW

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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)

Yes

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

2cf0de2b-f62f-4d37-a7f8-0210cce9f704

Public Version Date

July 16, 2020

Public Version Number

3

DI Record Publish Date

November 23, 2018

Package DI Number

D903410MW2

Quantity per Package

6

Contains DI Package

D903410MW1

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE