Catalog Number

-

Brand Name

Alpine BioMed

Version/Model Number

9033A0811AA

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

K140680

Product Code

GZL

Product Code Name

Electrode, Depth

Public Device Record Key

e645e838-ebf2-4e02-b776-81a1a6fe294f

Public Version Date

April 29, 2020

Public Version Number

4

DI Record Publish Date

August 25, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-