Catalog Number

SHG622-150

Brand Name

Port Access Needle

Version/Model Number

SHG622-150

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

3f114fc3-306a-481d-9f8e-a00c7383272e

Public Version Date

October 23, 2019

Public Version Number

3

DI Record Publish Date

August 03, 2016

Package DI Number

20801741089583

Quantity per Package

24

Contains DI Package

10801741089586

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BX