Catalog Number

-

Brand Name

JMS Sysloc A.V. Fistula Needle Set

Version/Model Number

824-1704

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

57dd5da9-a61c-486d-aa59-d9e5a90f0b6d

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

July 04, 2017

Package DI Number

38888483006114

Quantity per Package

50

Contains DI Package

08888483006113

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Inner Box