Catalog Number

-

Brand Name

Cannulated Drill Sterile 4.0-4.5MM

Version/Model Number

19236

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

K083490

Product Code

HTW

Product Code Name

Bit, Drill

Public Device Record Key

01e33472-6ec6-4b35-8687-9a5ffb6f179a

Public Version Date

May 14, 2019

Public Version Number

1

DI Record Publish Date

May 06, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-