Duns Number:008171162
Device Description: Sharps Container for disposal of e.g. needles and syringes (5 Qt. H Lid Red)
Catalog Number
-
Brand Name
Assure® SD Sharps Container
Version/Model Number
245001
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
K130281,K130281
Product Code
MMK
Product Code Name
Container, sharps
Public Device Record Key
6c98c6b9-a535-4067-b870-e8ff8ca63f3c
Public Version Date
March 08, 2021
Public Version Number
3
DI Record Publish Date
September 23, 2016
Package DI Number
10015482245013
Quantity per Package
20
Contains DI Package
00015482245016
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case Pack
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 30 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 50 |