MEDTRONIC - Medtronic Navigation Inc. Equipment Covers Clear - TIDI PRODUCTS, LLC

Duns Number:063519193

Device Description: Medtronic Navigation Inc. Equipment Covers Clear Polyethylene Sterile 10in x 102in x 1in 2

Want to know more about this Product? Request more information now!


More Product Details

Catalog Number

-

Brand Name

MEDTRONIC

Version/Model Number

24881

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

April 19, 2022

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)

Yes

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

PUI

Product Code Name

Drape, Surgical, Exempt

Device Record Status

Public Device Record Key

15ee806c-8b35-4fcc-9ef1-68bcc5e6b94a

Public Version Date

April 20, 2022

Public Version Number

3

DI Record Publish Date

October 07, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

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