Catalog Number

-

Brand Name

DragonFly™ BUR, DMD, RD, 95MM L, 1MM Ø

Version/Model Number

951-95-010

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

EQJ

Product Code Name

Bur, Ear, Nose And Throat

Public Device Record Key

f35d9f62-1b0e-41e4-95d3-237ed9ed41bf

Public Version Date

October 23, 2018

Public Version Number

1

DI Record Publish Date

September 22, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-