Catalog Number

-

Brand Name

QD-J M4

Version/Model Number

QD-J M4

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

-

Product Code

EFB

Product Code Name

Handpiece, air-powered, dental

Public Device Record Key

0aeb6f1c-65d5-41cd-9e74-307f563c0939

Public Version Date

December 29, 2021

Public Version Number

1

DI Record Publish Date

December 21, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-