Catalog Number

-

Brand Name

Angled handpiece for MIS spinal surgery burrs

Version/Model Number

1910NOU

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

GEY

Product Code Name

Motor, Surgical Instrument, Ac-Powered

Public Device Record Key

3ad5d34f-9616-4a25-aab8-96dd8aa82514

Public Version Date

November 22, 2018

Public Version Number

2

DI Record Publish Date

August 21, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-