Catalog Number

-

Brand Name

TIDI Shield

Version/Model Number

CFI-1504

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)

Yes

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

2bbd5c21-90aa-4012-a9a7-1b0af53e02ae

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

February 03, 2017

Package DI Number

00618125142552

Quantity per Package

20

Contains DI Package

01618125142551

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-