Catalog Number

9001-VC-005

Brand Name

ARROW

Version/Model Number

IPN033711

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

K141117,K141117,K141117

Product Code

FMI

Product Code Name

Needle, hypodermic, single lumen

Public Device Record Key

15e97aa9-66bb-499d-bafe-15f4c35804ab

Public Version Date

October 06, 2020

Public Version Number

6

DI Record Publish Date

September 16, 2016

Package DI Number

20816000011946

Quantity per Package

20

Contains DI Package

10816000011949

Package Discontinue Date

September 24, 2020

Package Status

Not in Commercial Distribution

Package Type

Carton