Catalog Number

615

Brand Name

Advocate Pen Needle 31G 8MM

Version/Model Number

615

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)

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

2b9d44fd-14b3-4a50-a639-6b86fefa32cd

Public Version Date

November 01, 2022

Public Version Number

6

DI Record Publish Date

August 20, 2016

Package DI Number

10894046001735

Quantity per Package

12

Contains DI Package

00894046001738

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case