Catalog Number

KN-2713RKT50

Brand Name

K-Pack II

Version/Model Number

KN-2713RKT50

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

K110850,K110850,K110850

Product Code

FMI

Product Code Name

Needle, Hypodermic, Single Lumen

Public Device Record Key

c82b421f-5c65-42c6-8d28-2b2dd23a0d84

Public Version Date

October 23, 2019

Public Version Number

4

DI Record Publish Date

May 07, 2018

Package DI Number

55413206223645

Quantity per Package

50

Contains DI Package

35413206223641

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton