Catalog Number

-

Brand Name

Medisystems Hemodialysis Fistula Needle Set with Masterguard Plus

Version/Model Number

S9-7615MGP

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

July 15, 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

37025c86-94f2-464e-b4e7-43ab3090517a

Public Version Date

July 17, 2020

Public Version Number

3

DI Record Publish Date

October 24, 2017

Package DI Number

10842289101743

Quantity per Package

200

Contains DI Package

00842289101746

Package Discontinue Date

July 15, 2020

Package Status

Not in Commercial Distribution

Package Type

Shipping Box