Catalog Number

32-2167

Brand Name

DeRoyal

Version/Model Number

32-2167

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

FMF

Product Code Name

Syringe, piston

Public Device Record Key

7589419a-b829-4349-ba6f-a137d1c97e52

Public Version Date

August 31, 2021

Public Version Number

1

DI Record Publish Date

August 23, 2021

Package DI Number

50749756989034

Quantity per Package

10

Contains DI Package

00749756989039

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case