N/A - SILICONE PAD 9732501 HEAD TRACKER 3PK - MEDTRONIC NAVIGATION, INC.

Duns Number:835233107

Device Description: SILICONE PAD 9732501 HEAD TRACKER 3PK

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More Product Details

Catalog Number

-

Brand Name

N/A

Version/Model Number

9732501

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

-

Product Code Details

Product Code

HAW

Product Code Name

Neurological stereotaxic Instrument

Device Record Status

Public Device Record Key

82ab56c9-d66a-42d3-8417-bb5e30e969aa

Public Version Date

January 12, 2021

Public Version Number

3

DI Record Publish Date

May 27, 2016

Additional Identifiers

Package DI Number

00613994155566

Quantity per Package

3

Contains DI Package

70613994155565

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

PK

"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