TIDIShield - TIDIShield Equipment Covers Clear Polyethylene - TIDI PRODUCTS, LLC

Duns Number:063519193

Device Description: TIDIShield Equipment Covers Clear Polyethylene Sterile 28in x 58in 10 per Case

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More Product Details

Catalog Number

-

Brand Name

TIDIShield

Version/Model Number

5467

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

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 Details

Product Code

KKX

Product Code Name

Drape, surgical

Device Record Status

Public Device Record Key

cd933136-7876-49fc-a07a-47b218122241

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

October 12, 2016

Additional Identifiers

Package DI Number

00618125142897

Quantity per Package

10

Contains DI Package

01618125142896

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-

"TIDI PRODUCTS, LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 222
2 A medical device with a moderate to high risk that requires special controls. 2255