Catalog Number

4657543-02

Brand Name

STERICAN™

Version/Model Number

4657543-02

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

3f35c0d6-9ee0-4a69-82d0-3c55147b76dc

Public Version Date

April 02, 2021

Public Version Number

5

DI Record Publish Date

September 23, 2016

Package DI Number

04046964333354

Quantity per Package

10

Contains DI Package

04046964333330

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton