Catalog Number

-

Brand Name

Clear Anatomical Face Mask

Version/Model Number

10-50502

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

-

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

BSJ

Product Code Name

Mask, Gas, Anesthetic

Public Device Record Key

1bef53e7-d767-4a77-85ce-ec23e0a5b35a

Public Version Date

July 30, 2018

Public Version Number

1

DI Record Publish Date

June 29, 2018

Package DI Number

30641043505025

Quantity per Package

20

Contains DI Package

10641043505021

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-