Catalog Number

FPCM040-1

Brand Name

Rally™

Version/Model Number

FPCM040-1

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

EHJ

Product Code Name

Disk, Abrasive

Public Device Record Key

e869398e-ba90-499a-81bf-e98d407eddaf

Public Version Date

May 04, 2020

Public Version Number

1

DI Record Publish Date

April 24, 2020

Package DI Number

10810038093885

Quantity per Package

30

Contains DI Package

00810038093888

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

FPCM040