Catalog Number

-

Brand Name

Revo Medical

Version/Model Number

RM1793

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

72900b8d-2c43-4a3b-9410-88a2dc13b5fc

Public Version Date

December 23, 2021

Public Version Number

1

DI Record Publish Date

December 15, 2021

Package DI Number

00850035252277

Quantity per Package

6

Contains DI Package

00850035252215

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case