Catalog Number

-

Brand Name

N/A

Version/Model Number

5330018

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"

Yes

For Single-Use

-

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

K182436

Product Code

HBE

Product Code Name

DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED)

Public Device Record Key

a741c7e9-5922-4ba6-b955-17891bbab047

Public Version Date

December 27, 2018

Public Version Number

1

DI Record Publish Date

November 26, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-