Catalog Number

RS-0003

Brand Name

CERVELLO SOFTWARE

Version/Model Number

RS-0003

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

-

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

GWK

Product Code Name

Conditioner, Signal, Physiological

Public Device Record Key

4af18e92-78b9-4648-8e44-6de9668eadb0

Public Version Date

July 12, 2019

Public Version Number

3

DI Record Publish Date

December 06, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-