Catalog Number

NM-0354

Brand Name

MORPHEUS

Version/Model Number

NM-0354

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

K071782

Product Code

GWK

Product Code Name

Conditioner, Signal, Physiological

Public Device Record Key

f439412e-a770-490a-a100-b156d9ef1940

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

December 07, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-