Duns Number:589153555
Device Description: 3 GALLON YELLOW SHARPS CONTAINER WITH LARGE OPENING LID
Catalog Number
303 040
Brand Name
BEMIS
Version/Model Number
303 040
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
K953797,K953797
Product Code
MMK
Product Code Name
Container, Sharps
Public Device Record Key
c8e240a4-7206-4c33-8db7-c4e0965548f2
Public Version Date
February 21, 2019
Public Version Number
4
DI Record Publish Date
September 24, 2016
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 4 |