Catalog Number

CP300PL

Brand Name

CHOICE PRO

Version/Model Number

CP300PL

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

August 08, 2022

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

-

Product Code

EFB

Product Code Name

Handpiece, Air-Powered, Dental

Public Device Record Key

61e6efbc-f416-4a0c-b8d1-7a15e4ded775

Public Version Date

August 11, 2022

Public Version Number

2

DI Record Publish Date

May 19, 2022

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-