Catalog Number

-

Brand Name

Alpine Biomed

Version/Model Number

9031C0601

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

April 28, 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

K944547

Product Code

GWF

Product Code Name

Stimulator, Electrical, Evoked Response

Public Device Record Key

daf6d778-859d-4b22-8856-1b6cd395f3d0

Public Version Date

April 29, 2020

Public Version Number

4

DI Record Publish Date

October 13, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-