Catalog Number

6007-003-100

Brand Name

NA

Version/Model Number

6007-003-100

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

-

Product Code

HAW

Product Code Name

Neurological stereotaxic Instrument

Public Device Record Key

78455ba6-bfca-4837-92db-249e2cee2236

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

August 24, 2016

Package DI Number

57613154107396

Quantity per Package

5

Contains DI Package

37613154107392

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

case