Catalog Number

-

Brand Name

Oak Ridge Products

Version/Model Number

0354-110M

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

K130281,K130281

Product Code

MMK

Product Code Name

Container, Sharps

Public Device Record Key

b0823e60-75a3-46b5-a9ff-fb3382de6f6e

Public Version Date

March 08, 2021

Public Version Number

3

DI Record Publish Date

September 22, 2016

Package DI Number

10865273000082

Quantity per Package

20

Contains DI Package

00865273000085

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case