Medtronic Navigation - SFW KIT 9735918 S8 STEREOTX 2ND LIC - MEDTRONIC NAVIGATION, INC.

Duns Number:835233107

Device Description: SFW KIT 9735918 S8 STEREOTX 2ND LIC

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More Product Details

Catalog Number

-

Brand Name

Medtronic Navigation

Version/Model Number

9735918

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

K203639

Product Code Details

Product Code

HAW

Product Code Name

Neurological stereotaxic Instrument

Device Record Status

Public Device Record Key

65f3df4c-d14d-4b35-95c2-44a9e80c8321

Public Version Date

April 29, 2022

Public Version Number

2

DI Record Publish Date

April 03, 2021

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