Catalog Number

-

Brand Name

Needle Free Spike

Version/Model Number

CBS

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

-

Product Code

KJG

Product Code Name

Tube, Tissue Culture

Public Device Record Key

6ad5e7ea-1202-4d85-a7d8-9fe16b9b62fd

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 23, 2016

Package DI Number

20816203020042

Quantity per Package

50

Contains DI Package

10816203020045

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case