Catalog Number

P1029

Brand Name

QUALA

Version/Model Number

P1029

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

EGS

Product Code Name

Handpiece, Contra- And Right-Angle Attachment, Dental

Public Device Record Key

59638cd8-87a5-4e3c-b8fc-2410a85fd977

Public Version Date

October 03, 2022

Public Version Number

1

DI Record Publish Date

September 25, 2022

Package DI Number

D6455215147

Quantity per Package

30

Contains DI Package

D023P10297

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE