Catalog Number

KN-2713RBKT50

Brand Name

K-Pack II

Version/Model Number

KN-2713RBKT50

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

May 07, 2018

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

K110850,K110850,K110850

Product Code

FMI

Product Code Name

Needle, Hypodermic, Single Lumen

Public Device Record Key

9b8ed0c7-fc07-4b4f-b6ba-07c2eec54846

Public Version Date

October 23, 2019

Public Version Number

6

DI Record Publish Date

May 19, 2017

Package DI Number

55413206211956

Quantity per Package

50

Contains DI Package

35413206211952

Package Discontinue Date

May 07, 2018

Package Status

Not in Commercial Distribution

Package Type

Carton