Catalog Number

8791

Brand Name

SharpSafety

Version/Model Number

8791

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

March 01, 2021

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)

-

Over the Counter (OTC)

Yes

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

02ba1215-34c6-472b-b2e0-736463786e50

Public Version Date

March 01, 2021

Public Version Number

9

DI Record Publish Date

September 24, 2016

Package DI Number

20884521022192

Quantity per Package

5

Contains DI Package

10884521022195

Package Discontinue Date

March 01, 2021

Package Status

Not in Commercial Distribution

Package Type

CASE