Catalog Number

IC40-D

Brand Name

Hummingbird® Cranial Access Kit

Version/Model Number

IC40D

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

9d1be062-3152-4279-93fd-eae498999803

Public Version Date

January 30, 2020

Public Version Number

2

DI Record Publish Date

October 10, 2019

Package DI Number

10868643000484

Quantity per Package

1

Contains DI Package

00868643000487

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box