Catalog Number

STC

Brand Name

Hummingbird®

Version/Model Number

STC

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

March 19, 2019

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

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K083378

Product Code

GWM

Product Code Name

Device, Monitoring, Intracranial Pressure

Public Device Record Key

94b36c57-5008-49b6-ae3d-0f65227f3a48

Public Version Date

February 09, 2021

Public Version Number

4

DI Record Publish Date

July 17, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-