Catalog Number

-

Brand Name

US DIAGNOSTICS Pen Needles, 31G x 8MM

Version/Model Number

100093

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

K160575,K160575,K160575,K160575

Product Code

FMI

Product Code Name

Needle, Hypodermic, Single Lumen

Public Device Record Key

3c382d65-0b2f-498b-acaa-a062dddef9f7

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

January 01, 2018

Package DI Number

20857513006296

Quantity per Package

5

Contains DI Package

10857513006299

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Outer box