Catalog Number

-

Brand Name

WOODPECKER

Version/Model Number

UI3

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K111290

Product Code

DZI

Product Code Name

Drill, Bone, Powered

Public Device Record Key

3b461566-ffa5-445b-bd8f-fb2f7d8ca2d6

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

October 21, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-