Catalog Number

8505-D

Brand Name

ultrapro Tx air

Version/Model Number

8505-D

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

September 05, 2018

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

d8edb136-32c0-49d6-8671-cdc9e4b1897c

Public Version Date

November 04, 2019

Public Version Number

4

DI Record Publish Date

July 02, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-