Catalog Number

-

Brand Name

Tracking Array for Brainpath

Version/Model Number

SYN-0015

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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

Yes

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

K153281,K153281

Product Code

HAW

Product Code Name

Neurological Stereotaxic Instrument

Public Device Record Key

962e7d8a-14f0-45a8-99c1-b48d6b67013a

Public Version Date

July 06, 2018

Public Version Number

4

DI Record Publish Date

September 24, 2016

Package DI Number

10670082000037

Quantity per Package

10

Contains DI Package

00670082000030

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-