Catalog Number

-

Brand Name

AIR-FLOW-PIEZON

Version/Model Number

FT-229-0B-302

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

-

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

K190124

Product Code

ELC

Product Code Name

Scaler, Ultrasonic

Public Device Record Key

b1db4414-07b6-433b-ba41-d0aadd0d493d

Public Version Date

November 19, 2019

Public Version Number

1

DI Record Publish Date

November 11, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-