Catalog Number

-

Brand Name

BONE TIP/BM-10P

Version/Model Number

BM-10P

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

-

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K080761

Product Code

DZI

Product Code Name

Drill, Bone, Powered

Public Device Record Key

e40296c6-0dbc-4476-8fa6-c26e3587e8fe

Public Version Date

July 26, 2018

Public Version Number

4

DI Record Publish Date

November 06, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-