Catalog Number

-

Brand Name

Medisystems Medic Anti-stick Needle/Connector

Version/Model Number

M8-5007

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

October 19, 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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

FMI

Product Code Name

Needle, Hypodermic, Single Lumen

Public Device Record Key

3a36dca0-602e-4c7a-a92a-a84df74a2911

Public Version Date

October 20, 2020

Public Version Number

3

DI Record Publish Date

September 16, 2016

Package DI Number

M535M850075

Quantity per Package

4

Contains DI Package

M535M850072

Package Discontinue Date

October 19, 2020

Package Status

Not in Commercial Distribution

Package Type

-