Catalog Number

KN-2038RB500P

Brand Name

K-Pack II

Version/Model Number

KN-2038RB500P

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

K984576,K984576,K984576

Product Code

FMI

Product Code Name

Needle, Hypodermic, Single Lumen

Public Device Record Key

85c41c7a-78c8-411b-a5c9-36649823ac21

Public Version Date

October 27, 2022

Public Version Number

6

DI Record Publish Date

October 24, 2016

Package DI Number

55413206216722

Quantity per Package

10

Contains DI Package

35413206216728

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton