Catalog Number

1380V

Brand Name

Sharps Away

Version/Model Number

1380V

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

-

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K943765

Product Code

FMI

Product Code Name

Needle, hypodermic, single lumen

Public Device Record Key

85675c62-3381-4d0d-8af6-7794315ac4c2

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 22, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-