Duns Number:028492788
Device Description: 3-gallon sharps container with Horizontal lid
Catalog Number
1330H
Brand Name
Sharps Away
Version/Model Number
1330H
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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
-
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K943765
Product Code
FMI
Product Code Name
Needle, hypodermic, single lumen
Public Device Record Key
b0e2325f-42fd-453e-827c-10a20848daf3
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 22, 2017
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. | 6 |