Catalog Number

1501235-001

Brand Name

Bur OSSEOSTAP diamond Ø1.8mm sterile

Version/Model Number

1501235

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

-

Product Code

EQJ

Product Code Name

Bur, Ear, Nose And Throat

Public Device Record Key

41fc4015-3e76-4dda-a601-af13f0eabde1

Public Version Date

June 04, 2020

Public Version Number

1

DI Record Publish Date

May 27, 2020

Package DI Number

27630055504672

Quantity per Package

1

Contains DI Package

17630055504675

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box