Plasti-Products - sharps container, red 5qt - PLASTI-PRODUCTS INC

Duns Number:153880372

Device Description: sharps container, red 5qt

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More Product Details

Catalog Number

-

Brand Name

Plasti-Products

Version/Model Number

141020

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

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

K970383,K970383,K970383

Product Code Details

Product Code

FMI

Product Code Name

Needle, Hypodermic, Single Lumen

Device Record Status

Public Device Record Key

f93d8bea-35f9-441f-bdc9-8aa28e93d3e1

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

April 15, 2016

Additional Identifiers

Package DI Number

20797876141022

Quantity per Package

10

Contains DI Package

10797876141025

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

box

"PLASTI-PRODUCTS INC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 4
2 A medical device with a moderate to high risk that requires special controls. 17