Catalog Number

8870

Brand Name

SharpSafety

Version/Model Number

8870

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

e6be6100-885f-4489-af21-7d40ef14882a

Public Version Date

February 15, 2019

Public Version Number

7

DI Record Publish Date

September 24, 2016

Package DI Number

20884521019277

Quantity per Package

5

Contains DI Package

30884521019274

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE