Catalog Number

5400005000

Brand Name

CORE, Maestro

Version/Model Number

5400005000

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

-

Product Code

HBB

Product Code Name

MOTOR, DRILL, PNEUMATIC

Public Device Record Key

48c21583-02ba-4d6e-9d22-3e7afda6ad1c

Public Version Date

November 22, 2018

Public Version Number

3

DI Record Publish Date

September 23, 2016

Package DI Number

34546540469091

Quantity per Package

10

Contains DI Package

04546540469090

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

pack