Catalog Number

1502175-001

Brand Name

0.6mm S2 Mini DIAMOND ROUND BUR

Version/Model Number

1502175

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

335d5640-013c-4715-9128-6f3e2a5645b5

Public Version Date

June 04, 2020

Public Version Number

1

DI Record Publish Date

May 27, 2020

Package DI Number

27630055504917

Quantity per Package

1

Contains DI Package

17630055504910

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box