Catalog Number

AN 3830WEG

Brand Name

Wegman's Unifine Pentips Plus - 8mmx31G

Version/Model Number

AN 3830WEG

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)

Yes

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K152339,K152339,K152339,K152339

Product Code

FMI

Product Code Name

Needle, Hypodermic, Single Lumen

Public Device Record Key

732efaa9-a35d-4382-939a-8f80a709f1c2

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 19, 2016

Package DI Number

00761059832546

Quantity per Package

24

Contains DI Package

00761059831549

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case