Catalog Number

-

Brand Name

JMS SYSLOC MINI A.V. FISTULA NEEDLE SET

Version/Model Number

864-1504

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

a3e5d2ac-964d-4233-8e85-01a2c4db5c28

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

June 27, 2017

Package DI Number

58888483006002

Quantity per Package

300

Contains DI Package

08888483006007

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-