Catalog Number

2001

Brand Name

AFP 810

Version/Model Number

AFP 810 Basic

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

-

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

EGY

Product Code Name

Processor, Radiographic-Film, Automatic, Dental

Public Device Record Key

3126e00d-0516-4ee0-94e1-c1edff746f3a

Public Version Date

June 27, 2019

Public Version Number

1

DI Record Publish Date

June 19, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-