Catalog Number

-

Brand Name

wenjian

Version/Model Number

WJ-144

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

K181691,K181691

Product Code

EFB

Product Code Name

Handpiece, Air-Powered, Dental

Public Device Record Key

31e50831-15a6-48ba-81f8-aba596de53ca

Public Version Date

April 05, 2021

Public Version Number

1

DI Record Publish Date

March 26, 2021

Package DI Number

16972249850276

Quantity per Package

120

Contains DI Package

06972249850279

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-