Catalog Number

-

Brand Name

Nipro Syringe

Version/Model Number

JD+03L2538-NIJ

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

K191359,K191359,K191359

Product Code

FMF

Product Code Name

Syringe, Piston

Public Device Record Key

9e0dfec5-28f0-4153-b4f5-ef6af0b9fa57

Public Version Date

April 26, 2021

Public Version Number

1

DI Record Publish Date

April 16, 2021

Package DI Number

10383790007266

Quantity per Package

100

Contains DI Package

00383790007269

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

box