Catalog Number

8938Y

Brand Name

SharpSafety

Version/Model Number

8938Y

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

MMK

Product Code Name

Container, sharps

Public Device Record Key

d3f0a1fb-d5b3-4440-a84f-20931fcb2223

Public Version Date

February 15, 2019

Public Version Number

7

DI Record Publish Date

January 07, 2017

Package DI Number

20884521022451

Quantity per Package

5

Contains DI Package

40884521022455

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE