Catalog Number

-

Brand Name

Ventriculostomy Kit - European

Version/Model Number

46154

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

K915546

Product Code

HBG

Product Code Name

DRILLS, BURRS, TREPHINES & ACCESSORIES (MANUAL)

Public Device Record Key

900507d1-6ab7-4d6d-a26d-a5d8f705c543

Public Version Date

September 20, 2021

Public Version Number

4

DI Record Publish Date

June 13, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-