Catalog Number

IC40

Brand Name

Hummingbird® Cranial Access Kit

Version/Model Number

IC40

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

d99dea2c-3b2b-46e9-bed4-e16944ef4a4b

Public Version Date

October 18, 2019

Public Version Number

1

DI Record Publish Date

October 10, 2019

Package DI Number

10868643000491

Quantity per Package

1

Contains DI Package

00868643000494

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box