Catalog Number

1100468-001

Brand Name

Bur PM2-70 80K full carbide Ø6.0mm sterile

Version/Model Number

1100468

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

a452ca60-95c2-4cc6-a51d-9de266a1d547

Public Version Date

June 08, 2020

Public Version Number

1

DI Record Publish Date

May 29, 2020

Package DI Number

27630055504238

Quantity per Package

1

Contains DI Package

17630055504231

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box