Catalog Number

-

Brand Name

HCS

Version/Model Number

HCS3013BK

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

-

Product Code

FXX

Product Code Name

Mask, Surgical

Public Device Record Key

c629a240-cb95-4878-bda6-29c2dea86d4a

Public Version Date

November 30, 2021

Public Version Number

3

DI Record Publish Date

October 19, 2021

Package DI Number

10849027005103

Quantity per Package

6

Contains DI Package

00849027005106

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case