SteathStation - SW KIT 9735895 S8 STLTH LINK SET - MEDTRONIC NAVIGATION, INC.

Duns Number:835233107

Device Description: SW KIT 9735895 S8 STLTH LINK SET

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


More Product Details

Catalog Number

-

Brand Name

SteathStation

Version/Model Number

9735895

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

15f461a9-995f-432d-afda-a1f9a592a034

Public Version Date

February 07, 2022

Public Version Number

1

DI Record Publish Date

January 29, 2022

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