N/A - SFTWR 9732110 FRAMELINK WORKSTATION - MEDTRONIC NAVIGATION, INC.

Duns Number:835233107

Device Description: SFTWR 9732110 FRAMELINK WORKSTATION

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More Product Details

Catalog Number

-

Brand Name

N/A

Version/Model Number

9732110

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

HAW

Product Code Name

Neurological stereotaxic Instrument

Device Record Status

Public Device Record Key

e1eb8d46-6b97-4eb6-be4d-e9550ff256a0

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

June 18, 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