Catalog Number

801-100

Brand Name

AllPro

Version/Model Number

801 DPA

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

Yes

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

EGS

Product Code Name

Handpiece, Contra- And Right-Angle Attachment, Dental

Public Device Record Key

39b4bb00-5813-43a8-89d9-8e13f4b2a902

Public Version Date

August 01, 2022

Public Version Number

1

DI Record Publish Date

July 24, 2022

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-