N/A - ADAPTER KIT 9734215 S7 POLESTAR - MEDTRONIC NAVIGATION, INC.

Duns Number:835233107

Device Description: ADAPTER KIT 9734215 S7 POLESTAR

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More Product Details

Catalog Number

-

Brand Name

N/A

Version/Model Number

9734215

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K032541

Product Code Details

Product Code

LNH

Product Code Name

System, nuclear magnetic resonance imaging

Device Record Status

Public Device Record Key

c7d530fc-a92c-48f9-9565-f28479dba8d2

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

June 04, 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