Catalog Number

-

Brand Name

MIDAS REX CURVED BUR

Version/Model Number

MR8-SP14MH30T

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

K183515,K183515

Product Code

HBE

Product Code Name

DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED)

Public Device Record Key

9d4a9d95-c248-4042-af86-108daf17f520

Public Version Date

May 02, 2022

Public Version Number

1

DI Record Publish Date

April 22, 2022

Package DI Number

20763000394596

Quantity per Package

5

Contains DI Package

00763000514020

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

PK