Catalog Number

931W

Brand Name

Medegen Medical products

Version/Model Number

931W

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

d9f93b06-06df-400d-a493-7e216fe4af79

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 23, 2016

Package DI Number

H362931W2

Quantity per Package

12

Contains DI Package

H362931W0

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-