Catalog Number

00022987000040

Brand Name

PIC INSUPEN

Version/Model Number

00022987000040

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

FMI

Product Code Name

Needle, Hypodermic, Single Lumen

Public Device Record Key

bca5221e-3359-42d7-a79b-ff741db4466a

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

October 05, 2016

Package DI Number

50815832020073

Quantity per Package

12

Contains DI Package

00815832020078

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

12 UNITS MASTER BOX