Catalog Number

-

Brand Name

BONE TIP/BM-RS02

Version/Model Number

BM-RS02

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

99432824-002f-4245-9133-49673708ab15

Public Version Date

July 31, 2018

Public Version Number

4

DI Record Publish Date

August 21, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-