Catalog Number

IC42

Brand Name

Hummingbird® Cranial Access Kit

Version/Model Number

IC42

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

Yes

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

-

Product Code

-

Product Code Name

-

Public Device Record Key

61e24e69-8682-41a2-95e2-c03f0a5a7667

Public Version Date

February 06, 2020

Public Version Number

1

DI Record Publish Date

January 29, 2020

Package DI Number

10850013266194

Quantity per Package

1

Contains DI Package

00850013266197

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box