N/A - UPGRADE 9734071 POLESTAR N20TON30 W SSA - MEDTRONIC NAVIGATION, INC.

Duns Number:835233107

Device Description: UPGRADE 9734071 POLESTAR N20TON30 W SSA

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More Product Details

Catalog Number

-

Brand Name

N/A

Version/Model Number

9734071

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"

-

For Single-Use

-

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

LNH

Product Code Name

System, nuclear magnetic resonance imaging

Device Record Status

Public Device Record Key

3b5bb95d-6b88-41d2-aa59-7af9adaf957a

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

June 20, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"MEDTRONIC NAVIGATION, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 23
2 A medical device with a moderate to high risk that requires special controls. 1961
3 A medical device with high risk that requires premarket approval 1