Catalog Number

9040DSA

Brand Name

TIDI

Version/Model Number

9040DSA

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

19339c14-9583-45f8-9ead-aae5e6e04d67

Public Version Date

May 06, 2020

Public Version Number

3

DI Record Publish Date

October 04, 2016

Package DI Number

00618125132867

Quantity per Package

50

Contains DI Package

01618125132866

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-