Catalog Number

305427

Brand Name

N/A

Version/Model Number

305427

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

K943141,K943141

Product Code

FMI

Product Code Name

Needle, hypodermic, single lumen

Public Device Record Key

f2f95c97-20a9-489a-84ae-c21c7c0b7558

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

March 20, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-