Catalog Number

-

Brand Name

Nordson Medical

Version/Model Number

SA-4400

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)

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

31942ef1-ad77-42af-a0b9-44f8806f7115

Public Version Date

November 01, 2022

Public Version Number

4

DI Record Publish Date

March 30, 2021

Package DI Number

10815634020877

Quantity per Package

5

Contains DI Package

00815634020870

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Inner Pack