Catalog Number

320881

Brand Name

BD Ultra-Fine Pen Needles, 31G x 8MM Mail Order

Version/Model Number

320881

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

K131358,K131358,K131358

Product Code

FMI

Product Code Name

Needle, hypodermic, single lumen

Public Device Record Key

07356871-075f-4c66-b026-db5ab41f85bd

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

August 03, 2016

Package DI Number

50382903208819

Quantity per Package

12

Contains DI Package

00382903208814

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case