Catalog Number

-

Brand Name

Medisystems Single Needle Set

Version/Model Number

M9-3006

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

July 06, 2020

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"

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

FIE

Product Code Name

Needle, Fistula

Public Device Record Key

e08ecf84-aa18-4133-99d9-2e7b82b904dd

Public Version Date

July 07, 2020

Public Version Number

3

DI Record Publish Date

March 08, 2017

Package DI Number

20842289101184

Quantity per Package

10

Contains DI Package

10842289101187

Package Discontinue Date

July 06, 2020

Package Status

Not in Commercial Distribution

Package Type

Shipping Box