Catalog Number

-

Brand Name

Medisystems Hemodialysis Fistula Needle Set

Version/Model Number

S9-5005

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

December 31, 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

82bdc37c-fc17-40ed-a2c1-e65c31d43428

Public Version Date

February 19, 2021

Public Version Number

3

DI Record Publish Date

September 16, 2016

Package DI Number

10842289100937

Quantity per Package

250

Contains DI Package

00842289100930

Package Discontinue Date

December 31, 2020

Package Status

Not in Commercial Distribution

Package Type

-