Catalog Number

-

Brand Name

JMS A.V.FISTULA NEEDLE SET (SINGLE TYPE)

Version/Model Number

820-3500

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

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"

-

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

8b902a2d-acfe-47e4-9ed6-cf423016f7ed

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 23, 2016

Package DI Number

58888483005166

Quantity per Package

10

Contains DI Package

38888483005162

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-