Catalog Number

35-412NS

Brand Name

DeRoyal

Version/Model Number

35-412NS

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"

Yes

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

GAX

Product Code Name

TOURNIQUET, NONPNEUMATIC

Public Device Record Key

8b9ef099-ce5d-4f61-9ce9-0fb4b966b5cd

Public Version Date

December 08, 2021

Public Version Number

2

DI Record Publish Date

July 12, 2021

Package DI Number

50749756173631

Quantity per Package

20

Contains DI Package

00749756173636

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case