Catalog Number

8705

Brand Name

Medegen Medical products

Version/Model Number

8705

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

June 01, 2020

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

c382511d-ca64-486b-a5df-b9788faab4a1

Public Version Date

June 01, 2020

Public Version Number

5

DI Record Publish Date

September 23, 2016

Package DI Number

H36287052

Quantity per Package

10

Contains DI Package

H36287050

Package Discontinue Date

June 01, 2020

Package Status

Not in Commercial Distribution

Package Type

-