Catalog Number

FPCF010-1

Brand Name

Rally™

Version/Model Number

FPCF010-1

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

EHL

Product Code Name

Point, Abrasive

Public Device Record Key

775d24dc-1c81-4f19-b989-c33fc6d4dd4f

Public Version Date

May 04, 2020

Public Version Number

1

DI Record Publish Date

April 24, 2020

Package DI Number

10810038093847

Quantity per Package

15

Contains DI Package

00810038093840

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

FPCF010-X