Catalog Number

-

Brand Name

POWEREASE™ Instruments

Version/Model Number

2346030

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K111520

Product Code

HBE

Product Code Name

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

Public Device Record Key

58374181-683a-499a-a6fd-cd0dd94e5c87

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

April 18, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-