Catalog Number

C0258

Brand Name

Resident Expert Software Module

Version/Model Number

C0258-00808

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

August 04, 2020

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

-

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

K092192

Product Code

HAW

Product Code Name

Neurological stereotaxic Instrument

Public Device Record Key

8b286afa-fcb4-4e7c-9528-7c5c460b4d89

Public Version Date

August 05, 2020

Public Version Number

2

DI Record Publish Date

March 28, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-