Catalog Number

18-3105

Brand Name

Easydrip Insulin Penneedle

Version/Model Number

18-3105

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"

-

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

79d780d1-561a-4a87-bb7a-c5225ec84606

Public Version Date

May 18, 2020

Public Version Number

2

DI Record Publish Date

May 03, 2018

Package DI Number

26945630104392

Quantity per Package

20

Contains DI Package

16945630104395

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case