Catalog Number

-

Brand Name

WOODPECKER

Version/Model Number

GW4

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

K053555

Product Code

ELC

Product Code Name

Scaler, Ultrasonic

Public Device Record Key

d899f1ad-95da-4c82-bfdb-69e700b4f840

Public Version Date

October 24, 2022

Public Version Number

4

DI Record Publish Date

October 23, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-