Catalog Number

KN-S2516RB

Brand Name

K-Pack Surshield™

Version/Model Number

KN-S2516RB

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

K110527,K110527

Product Code

FMI

Product Code Name

Needle, Hypodermic, Single Lumen

Public Device Record Key

c69da97a-c36c-4247-8200-8fddd2ace718

Public Version Date

October 23, 2019

Public Version Number

5

DI Record Publish Date

September 05, 2016

Package DI Number

55413206050265

Quantity per Package

1500

Contains DI Package

05413206050260

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton