Catalog Number

AN 3840WEG

Brand Name

Wegman's Unifine Pentips Plus - 4mmx32G

Version/Model Number

AN 3840WEG

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)

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

61e04b26-3ddf-4277-8bf7-48953498b5c7

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 19, 2016

Package DI Number

00761059841548

Quantity per Package

6

Contains DI Package

00077890352373

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Sleeve