Catalog Number

-

Brand Name

Easy Glide Pen Needle 31G X 5/16" (8mm)

Version/Model Number

668315

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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)

-

Over the Counter (OTC)

Yes

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

24d02f97-dd60-4cb2-8198-0ac56ed8f459

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 16, 2016

Package DI Number

B2086683153

Quantity per Package

8

Contains DI Package

B2086683152

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Shipping Case