Catalog Number

-

Brand Name

Nordson Medical

Version/Model Number

SA-4460

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

91625a9f-f5d2-4cda-b073-b0f923be97cc

Public Version Date

April 07, 2021

Public Version Number

1

DI Record Publish Date

March 30, 2021

Package DI Number

10815634020884

Quantity per Package

5

Contains DI Package

00815634020887

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Inner pack