Catalog Number

-

Brand Name

DTE,WOODPECKER

Version/Model Number

MT3

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K203706

Product Code

EBW

Product Code Name

Controller, Foot, Handpiece And Cord

Public Device Record Key

5c9ddcb1-28fc-4f8c-87c1-b98b8de44db6

Public Version Date

August 23, 2022

Public Version Number

1

DI Record Publish Date

August 15, 2022

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-