Catalog Number

W01219

Brand Name

ARES 620 Unicorder System

Version/Model Number

620

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

K160499

Product Code

ETN

Product Code Name

STIMULATOR, NERVE

Public Device Record Key

994c394b-44fd-45a0-ac99-6851e3a75d01

Public Version Date

March 22, 2022

Public Version Number

5

DI Record Publish Date

May 19, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-