Catalog Number

8716V

Brand Name

Medegen Medical products

Version/Model Number

8716V

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K942054,K942054

Product Code

FMI

Product Code Name

Needle, hypodermic, single lumen

Public Device Record Key

d3039a1e-c19d-4538-8721-855f4f44c625

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 23, 2016

Package DI Number

H3628716V2

Quantity per Package

6

Contains DI Package

H3628716V0

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-