Duns Number:544557314
Device Description: MA1321 2GALLON
Catalog Number
-
Brand Name
Maxcon Sharps Container
Version/Model Number
MA1321
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
October 08, 2021
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
K180984
Product Code
MMK
Product Code Name
Container, Sharps
Public Device Record Key
67fe3872-d73d-4be6-9a10-c6b85d5aa407
Public Version Date
October 18, 2021
Public Version Number
1
DI Record Publish Date
October 08, 2021
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. | 9 |