Catalog Number

43565

Brand Name

Marketlab Inc

Version/Model Number

43565

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"

Yes

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

FMI

Product Code Name

Needle, hypodermic, single lumen

Public Device Record Key

5cc6f913-b417-4437-ac80-3d5d3fcc7891

Public Version Date

December 17, 2018

Public Version Number

1

DI Record Publish Date

November 16, 2018

Package DI Number

00817517020786

Quantity per Package

50

Contains DI Package

00817517020779

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-