Catalog Number

-

Brand Name

Needle, Hypodermic, Single Lumen

Version/Model Number

19B-B

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

FMI

Product Code Name

Needle, Hypodermic, Single Lumen

Public Device Record Key

edaa9c45-1679-4cc9-b821-c059258b9f07

Public Version Date

October 23, 2019

Public Version Number

5

DI Record Publish Date

May 23, 2016

Package DI Number

10816513020155

Quantity per Package

2000

Contains DI Package

00816513020158

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BOX