Catalog Number

SUDN022

Brand Name

Rospital Productos Medicos

Version/Model Number

SUDN022

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

94c69272-5ee2-44cc-8077-7540aa61a7b9

Public Version Date

June 22, 2020

Public Version Number

1

DI Record Publish Date

June 13, 2020

Package DI Number

10812460027353

Quantity per Package

100

Contains DI Package

00812460027356

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

INNER