Catalog Number

9033S0571

Brand Name

Keypoint

Version/Model Number

9033S0571

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

K944547

Product Code

GWF

Product Code Name

Stimulator, Electrical, Evoked Response

Public Device Record Key

d81df168-56a1-4db7-8292-727b1dcf5f42

Public Version Date

April 03, 2019

Public Version Number

1

DI Record Publish Date

March 26, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-