Catalog Number

8851

Brand Name

SharpSafety

Version/Model Number

8851

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)

-

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

15cdffed-95cd-4296-a300-561062b96ac1

Public Version Date

February 15, 2019

Public Version Number

7

DI Record Publish Date

September 24, 2016

Package DI Number

20884521019253

Quantity per Package

10

Contains DI Package

30884521019250

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE