Catalog Number

SHN19-60

Brand Name

Port Access Needle

Version/Model Number

SHN19-60

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

FPA

Product Code Name

Set, administration, intravascular

Public Device Record Key

c69c002c-046a-4af7-978b-c3c6886252ef

Public Version Date

October 23, 2019

Public Version Number

3

DI Record Publish Date

August 05, 2016

Package DI Number

10801741089654

Quantity per Package

25

Contains DI Package

00801741089657

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CA