Clear Anatomical Face Mask - MERCURY ENTERPRISES, INC.

Duns Number:032705659

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More Product Details

Catalog Number

-

Brand Name

Clear Anatomical Face Mask

Version/Model Number

10-50501

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

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 Details

Product Code

BSJ

Product Code Name

Mask, Gas, Anesthetic

Device Record Status

Public Device Record Key

cbf69565-fce6-433b-96fe-c4d96c6db027

Public Version Date

July 30, 2018

Public Version Number

1

DI Record Publish Date

June 29, 2018

Additional Identifiers

Package DI Number

30641043505018

Quantity per Package

30

Contains DI Package

10641043505014

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-

"MERCURY ENTERPRISES, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 120
2 A medical device with a moderate to high risk that requires special controls. 728