Catalog Number

320617

Brand Name

Pen Needle

Version/Model Number

681131386807

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)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K162516,K162516,K162516

Product Code

FMI

Product Code Name

Needle, hypodermic, single lumen

Public Device Record Key

b8b42c23-b6f6-4588-9144-a6fddaafc68f

Public Version Date

October 18, 2022

Public Version Number

1

DI Record Publish Date

October 10, 2022

Package DI Number

50382903206174

Quantity per Package

18

Contains DI Package

00681131386807

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case