Catalog Number

FT-188#HF/A

Brand Name

AIR-FLOW

Version/Model Number

C

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

K082791

Product Code

EFB

Product Code Name

Handpiece, Air-Powered, Dental

Public Device Record Key

0d0e08bb-4db4-4391-926f-3fbdb998f594

Public Version Date

January 14, 2019

Public Version Number

1

DI Record Publish Date

December 13, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-