Catalog Number

-

Brand Name

masterguard APHERESIS NEEDLE

Version/Model Number

P9-7115MG

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"

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

3d08b019-e2cd-4147-8d7e-7374c3395bea

Public Version Date

April 07, 2021

Public Version Number

2

DI Record Publish Date

July 06, 2020

Package DI Number

10842289102702

Quantity per Package

250

Contains DI Package

00842289102705

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Shipping Box