Catalog Number

FCD200/A

Brand Name

Finale®

Version/Model Number

00884450034354

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

GAX

Product Code Name

TOURNIQUET, NONPNEUMATIC

Public Device Record Key

15b10c36-6023-49d2-a771-da7e6bc0c2a0

Public Version Date

October 22, 2018

Public Version Number

1

DI Record Publish Date

September 21, 2018

Package DI Number

20884450034358

Quantity per Package

4

Contains DI Package

10884450034351

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-