Catalog Number

-

Brand Name

Resilient Medical Solutions

Version/Model Number

RMEM1

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

161d450c-d88f-4d4e-8ccd-93a696fadc76

Public Version Date

June 22, 2022

Public Version Number

1

DI Record Publish Date

June 14, 2022

Package DI Number

10850037100054

Quantity per Package

10

Contains DI Package

00850037100057

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

case