Catalog Number

9030A

Brand Name

TIDI

Version/Model Number

9030A

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)

Yes

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

0e00fb24-cbd7-4b8a-9ae4-9a6fa6ccb319

Public Version Date

February 12, 2021

Public Version Number

1

DI Record Publish Date

February 04, 2021

Package DI Number

10618125189974

Quantity per Package

10

Contains DI Package

00618125189977

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-