Catalog Number

-

Brand Name

Easy Glide Pen Needle 33G X 5/32" (4mm)

Version/Model Number

663304

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

e7be09ec-85ce-43df-8229-8ad9bf189d67

Public Version Date

June 11, 2018

Public Version Number

1

DI Record Publish Date

May 10, 2018

Package DI Number

B2086633041

Quantity per Package

100

Contains DI Package

B2086633040

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box