Catalog Number

12-B20

Brand Name

HiCUT Burs

Version/Model Number

2.0 mm balltip

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

K130755

Product Code

HBE

Product Code Name

Drills, Burrs, Trephines & Accessories (Simple, Powered)

Public Device Record Key

5499c20d-1982-4b0c-9304-c89787ad6add

Public Version Date

June 21, 2021

Public Version Number

1

DI Record Publish Date

June 11, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-