Catalog Number

21026A

Brand Name

TIDISHIELD

Version/Model Number

21026A

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

KQM

Product Code Name

Camera, Surgical And Accessories

Public Device Record Key

0e2eeae3-4535-41d7-b9f9-1268ff9a2eb1

Public Version Date

May 14, 2021

Public Version Number

1

DI Record Publish Date

May 06, 2021

Package DI Number

10618125161079

Quantity per Package

5

Contains DI Package

00618125161072

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-