Catalog Number

-

Brand Name

Universal Sharps Container

Version/Model Number

SC0015

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)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K925816

Product Code

FMI

Product Code Name

Needle, Hypodermic, Single Lumen

Public Device Record Key

352a613d-5790-43b7-880f-60226b818a57

Public Version Date

February 28, 2022

Public Version Number

1

DI Record Publish Date

February 20, 2022

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-