Catalog Number

-

Brand Name

CUSMED FACE MASK

Version/Model Number

9600.0000.00

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

-

Product Code

LYU

Product Code Name

Accessory, Surgical Apparel

Public Device Record Key

5ce5d6ac-50e1-4299-b39d-c55212a65190

Public Version Date

March 31, 2021

Public Version Number

1

DI Record Publish Date

March 23, 2021

Package DI Number

14717002404387

Quantity per Package

50

Contains DI Package

04717002404380

Package Discontinue Date

March 23, 2021

Package Status

Not in Commercial Distribution

Package Type

Box